Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), including the Instructions for use, as described in the Clinical Investigation Plan, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; conducts the Study according to the Clinical Investigation Plan without changes except as provided in clause or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the Clinical Investigation Plan are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; ensures that the Sponsor’s prior written consent and the approval of the Reviewing HREC are obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Clinical Investigation Plan, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the Clinical Investigation Plan; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 5 contracts

Samples: Research Agreement, Research Agreement, Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise ~~required~~ required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; ensures that the Sponsor’s prior written consent ~~and the approval of the Reviewing HREC are~~ is obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan,~~ Protocol and relevant ethical and regulatory guidelines, ~~and~~ and, in the case of the Institution and the Reviewing ~~HREC~~ HREC, with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. ~~Institution Obligations and Responsibilities~~ INSTITUTION OBLIGATIONS AND RESPONSIBILITIES If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants ~~that~~ that, to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with ~~Clinical Investigation Plan~~the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the ~~Clinical Investigation Plan,~~ Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study ~~Materials~~ related materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access is to take place at times mutually ~~agreed~~ agreed, during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the ~~Clinical Investigation Plan~~Protocol, provided that any amendments to the ~~Clinical Investigation Plan~~ Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel ~~available for the Study~~ for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the ~~Clinical Investigation Plan~~Protocol, Investigational Product(s), and their ~~Study~~ Study-related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, ~~Clinical Investigation Plan~~Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution ~~must~~ will ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution ~~must~~ will provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. ~~Sponsor Obligations and responsibilities~~ SPONSOR OBLIGATIONS AND RESPONSIBILITIES Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, ~~and~~ and, through the Principal ~~Investigator~~ Investigator, the Institution and the Reviewing HREC, ~~the Investigator’s Brochure and~~ with all current and relevant ~~information, including the Instructions for use,~~ information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor ~~must~~ will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor ~~must~~ will designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor ~~must~~ will monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal ~~Investigator~~ Investigator, and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor ~~must~~ will notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor ~~must~~ will cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor ~~must~~ will provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor ~~must~~ will provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant ~~Medical Technology Association of~~ Medicines Australia Form of Indemnity for Clinical ~~Investigations~~ Trials as set out in Schedule 3. The Sponsor will comply with the ~~Medical Technology Association of~~ Medicines Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored ~~clinical investigation~~ Trial as specified in Schedule 5. The Sponsor ~~must~~ will maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 4 contracts

Samples: monashhealth.org, monashhealth.org, monashhealth.org

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the Sponsor; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise ~~required~~ required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; ensures that the Sponsor’s prior written consent ~~and the approval of the Reviewing HREC are~~ is obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan,~~ Protocol and relevant ethical and regulatory guidelines, ~~and~~ and, in the case of the Institution and the Reviewing ~~HREC~~ HREC, with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 3 contracts

Samples: monashhealth.org, www.sjog.org.au, www.sjog.org.au

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises ~~himself or herself~~ themselves with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and ~~Sponsor~~ CRG prior to implementation of the amendment; ~~ensures that~~ as soon as is practical advises the ~~Sponsor’s prior written consent and~~ CRG if the Responsible HREC alters its approval of the ~~Reviewing~~ Study; obtains prior written approval from the CRG and the Responsible HREC ~~are obtained~~ of any proposed advertisements to ~~any advertisement~~ be used for the purpose of Study Participant recruitment in ~~respect of~~ the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses ~~his or her~~ their best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the ~~Sponsor~~CRG, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 3 contracts

Samples: Research Agreement, www.rch.org.au, www.medicinesaustralia.com.au

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and ~~responsibilities~~ Responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the ~~Reviewing HREC~~ Responsible EC and the Institution prior to Study initiation. Written documentation of approval by the ~~Reviewing HREC~~ Responsible EC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the ~~Reviewing HREC~~ Responsible EC (as applicable) in accordance with 2.3, and ~~Sponsor~~ the CRG has consented to the amendment in writing prior to implementation of the amendment; ensures that ~~the Sponsor’s~~ prior written ~~consent~~ approval is obtained from the CRG and the ~~approval of the Reviewing HREC are obtained to~~ Responsible EC for any advertisement in respect of the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; ~~notifies~~ Notifies the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC~~ Responsible EC (as applicable) of any Adverse Events (including Serious Adverse Events) ~~that occur during the course of the Study~~ in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the ~~Reviewing HREC~~ Responsible EC, with their policies and procedures; completes Case Report Forms within the agreed time period, as described in Schedule 4. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant ~~prior to their enrolment~~ in accordance with the ~~Study~~ informed consent process approved by the Responsible EC and is documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC, provided however that where a Study Participant~~ Responsible EC; as soon as is ~~unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements~~ practical advises the CRG if the Responsible EC alters its approval of the ~~Reviewing HREC.~~ Study; Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must Notify the CRG as soon as is practical; the Institution must consult with the ~~Sponsor~~ CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both ~~parties~~Parties; and if a replacement cannot be found who is acceptable to both Parties, the ~~Sponsor~~ CRG may require recruitment into the Study by the Institution to cease, ~~or move~~ and the ~~Study to a different Study Site~~CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses ~~3.3(2~~3.3(1), (32), (54), (8), (10), (11), (13) ), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, ~~it and~~ it, its affiliates and any ~~other~~ person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory ~~Authority~~Authority for debarment. Furthermore, the Institution shall ~~notify~~ Notify the ~~Sponsor~~ CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution ~~will not~~ must not, and must ensure that its Personnel involved in the conduct of the Study do not, engage in any conduct on the ~~Sponsor~~CRG’s behalf which is in violation of, or potentially in violation of, any applicable ~~local or foreign~~ New Zealand laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits to the Study Site in accordance with ~~Clinical Investigation Plan~~the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the ~~Clinical Investigation Plan,~~ Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study ~~Materials~~ related materials and its Personnel as soon as is reasonably possible upon request by the ~~Sponsor~~CRG, Regulatory Authority, ~~Reviewing HREC~~ Responsible EC or any third party reasonably designated by the ~~Sponsor~~CRG. Any such access is to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the ~~Clinical Investigation Plan~~Protocol, provided that any amendments to the ~~Clinical Investigation Plan~~ Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the ~~Reviewing HREC~~Responsible EC (as applicable). The Institution will have an adequate number of appropriately qualified Personnel ~~available for the Study~~ for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the ~~Clinical Investigation Plan~~Protocol, Investigational ~~Product(s)~~Product, and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, ~~Clinical Investigation Plan~~Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of ~~Sponsor~~CRG. The Institution agrees to ~~notify~~ Notify the ~~Sponsor~~ CRG before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the ~~Sponsor~~ CRG at the ~~Sponsor~~CRG’s expense. The Institution ~~must~~ will ensure that the Study is subject to the continuing oversight of the ~~Reviewing HREC~~ Responsible EC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately ~~notify~~ Notify the ~~Sponsor~~CRG, unless prevented from doing so by law. The Institution ~~must~~ will provide the ~~Sponsor~~ CRG with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit or inspection of the Institution or Study Site. This includes execution of any documents reasonably requested by the ~~Sponsor~~ CRG in connection with the requirements of a Regulatory Authority or the ~~Sponsor~~ CRG as a result of such an ~~audit~~audit or inspection. ~~The cost will~~ Any costs resulting from such audit shall be borne equally by the ~~Sponsor~~ Parties, unless ~~such rectification is due to~~ the ~~default~~ cost has resulted solely from an act or omission of a Party, in which case that Party will bear the ~~Institution or the Principal Investigator~~total costs. The Institution shall obtain approval, in writing, from the ~~Sponsor~~ CRG for any ~~press~~ media statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. ~~Sponsor~~ The Institution is responsible for ensuring that the Principal Investigator has a robust procedure in place prior to the commencement of the Study, for the review of all safety information (whether internal or provided by the CRG) by appropriately qualified members of the Study staff. The Institution agrees to listing of trial particulars, including Investigator name and site address, as may be required by law, on reputable clinical trial registries (e.g. xxxxxxxxxxxxxx.xxx). CRG Obligations and ~~responsibilities~~ Responsibilities CRG warrants that it has the capacity and the authority to enter into this Agreement and to perform its obligations under this Agreement. Prior to the Agreement being executed, the ~~Sponsor must~~ CRG or its designate will provide the Principal Investigator, and through the Principal Investigator the Institution and the ~~Reviewing HREC~~Responsible EC, ~~the Investigator’s Brochure and~~ with all current and relevant ~~information, including the Instructions for use,~~ information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The ~~Sponsor must~~ CRG or its designee will act as the applicant for the purposes of an application for approval of a clinical trial under Section 30 of the Medicines Act. The CRG or designee is responsible for ensuring the preparation and submission of all documents required by Medsafe for initiating and conducting the study. The CRG will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The ~~Sponsor must~~ CRG will designate appropriately qualified ~~personnel~~ Personnel to advise on Study-related medical questions or problems. The ~~Sponsor must~~ CRG will monitor the application of the Investigational Product in other places (both within and outside ~~Australia)~~ New Zealand as applicable), and advise the Institution, through the Principal Investigator and ~~TGA~~ Medsafe, of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The ~~Sponsor must notify~~ CRG will Notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The ~~Sponsor must~~ CRG will cooperate with the Institution and/or the ~~Reviewing HREC~~ Responsible EC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the ~~Sponsor must~~ CRG will provide the Institution with adequate information and all necessary Investigational Product accountability forms. The ~~Sponsor must provide indemnity to~~ CRG warrants that the ~~Institution and members~~ Study is not being conducted principally for the benefit of the ~~Reviewing HREC against claims arising from~~ Manufacturer or distributor of the Investigational Product in respect of which the trial is being carried out. The CRG will register the Study on the ~~terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity~~ appropriate clinical trial registry or registries (for ~~Clinical Investigations as set out in Schedule 3~~example; xxxxxxxxxxxxxx.xxx or ANZCTR). The ~~Sponsor will comply~~ CRG further warrant that the information submitted to the Responsible EC is accurate and complete and that the nature of the relationship with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities Investigational Product Manufacturer is fully and ~~indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time~~accurately disclosed.

Appears in 2 contracts

Samples: Research Agreement, Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Local Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~Local Sponsor or the Organisation; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Local Sponsor; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without changes except as provided in clause 2.2, or 2.3, or as agreed to in writing by the Local Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Local Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise ~~required~~ required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and Local Sponsor prior to implementation of the amendment; ensures that the Local Sponsor’s 's prior written consent ~~and the approval of the Reviewing HREC are~~ is obtained to any advertisement in respect of the Study; provides the Local Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Local Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Local Sponsor or the Organisation visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Local Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan,~~ Protocol and relevant ethical and regulatory guidelines, ~~and~~ and, in the case of the Institution and the Reviewing ~~HREC~~ HREC, with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Local Sponsor; provides regular written progress reports to the Local Sponsor in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the Local Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Local Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 2 contracts

Samples: www.sjog.org.au, www.sjog.org.au

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and ~~Sponsor~~ CRG prior to implementation of the amendment; ~~ensures that~~ as soon as is practical advises the ~~Sponsor’s prior written consent and~~ CRG if the Responsible HREC alters its approval of the ~~Reviewing~~ Study; obtains prior written approval from the CRG and the Responsible HREC ~~are obtained~~ of any proposed advertisements to ~~any advertisement~~ be used for the purpose of Study Participant recruitment in ~~respect of~~ the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the ~~Sponsor~~CRG, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 2 contracts

Samples: www.sjog.org.au, www.sjog.org.au

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ Organisation and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~Organisation; ensures written approval has been obtained to conduct the Study from the ~~Reviewing~~ Responsible HREC and the Institution prior to Study initiation. ~~Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor;~~ conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without changes except as provided in clause or 2.3, or as agreed to in writing by the ~~Sponsor~~ Organisation and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the ~~Reviewing~~ Responsible HREC and ~~Sponsor~~ the Organisation prior to implementation of the amendment; ensures that the Sponsor’s prior written consent and the approval of the Reviewing HREC are obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the ~~Sponsor~~Organisation, the Institution and the ~~Reviewing~~ Responsible HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the ~~Reviewing~~ Responsible HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the Clinical Investigation Plan; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study ~~Participant~~ Subject prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~Organisation, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing Responsible HREC. ~~Institution~~ INSTITUTION Obligations and ~~Responsibilities~~ responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be ~~available then:~~ available, the Institution must consult with the ~~Sponsor~~ Organisation and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both ~~parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site~~Parties. If the ~~Principal Investigator fails to carry out those obligations specified in clauses 3.3(2)~~parties cannot agree on a replacement, (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of either party may terminate this Agreement ~~relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved~~ in ~~the conduct of the Study, including the Principal Investigator, are properly registered~~ accordance with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or banclause 13.5. The Institution will not engage in any conduct on the ~~Sponsor~~Organisation’s behalf which is in violation of, or potentially in violation of, any applicable local ~~or foreign~~ laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the ~~Clinical Investigation Plan~~Protocol, provided that any amendments to the ~~Clinical Investigation Plan~~ Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the ~~Institution and the Reviewing~~ Responsible HREC. The Institution will have an adequate number of appropriately qualified Personnel ~~available for the Study~~ for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the ~~Clinical Investigation Plan~~Protocol, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study ~~Participants~~ Subjects will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, ~~Clinical Investigation Plan~~Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of ~~Sponsor~~Organisation. The Institution agrees to notify the ~~Sponsor~~ Organisation before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the ~~Sponsor~~ Organisation at the ~~Sponsor~~Organisation’s expense. The Institution ~~must~~ will ensure that the Study is subject to the continuing oversight of the ~~Reviewing~~ Responsible HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor ORGANISATION Obligations and responsibilities Prior to the Agreement being executed, the ~~Sponsor must~~ Organisation will provide the Principal Investigator, and through the Principal Investigator the Institution and the ~~Reviewing~~ Responsible HREC, ~~the Investigator’s Brochure and~~ with all current and relevant ~~information, including the Instructions for use, regarding the Investigational Product as reasonably~~ information that is required to justify the nature, scope and duration of the ~~Study~~Study and to the extent that it is relevant to the Protocol. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must Organisation will notify the Institution of any Adverse Events (including Serious Adverse Events) of which it becomes aware that occur during the course of the Study ~~(either at the Study Site or other study sites, including overseas sites)~~ which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study ~~Participants~~Subjects. The ~~Sponsor must~~ Organisation will cooperate with the Institution and/or the ~~Reviewing~~ Responsible HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 2 contracts

Samples: Research Agreement, Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the ~~Investigational~~ Study Product(s)~~, including the Instructions for use~~, as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the ~~Investigational~~ Study Product and any other information sources provided by the Sponsor; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘“Disclosure: Financial Interests and Arrangements of Clinical Investigators”) before the commencement of the Study and as otherwise ~~required~~ required, and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; ensures that the Sponsor’s prior written consent ~~and the approval of the Reviewing HREC are~~ is obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan,~~ Protocol and relevant ethical and regulatory guidelines, ~~and~~ and, in the case of the Institution and the Reviewing ~~HREC~~ HREC, with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 2 contracts

Samples: www.sjog.org.au, www.sjog.org.au

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the Sponsor and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the ~~Investigational~~ Study Product(s), including the Instructions for use, as described in the Clinical Investigation Plan, ~~Investigator’s Brochure,~~ information relating to the ~~Investigational~~ Study Product and any other information sources provided by the Sponsor; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the Sponsor; conducts the Study according to the Clinical Investigation Plan without changes except as provided in clause or 2.3, or as agreed to in writing by the Sponsor and the Institution and approved in accordance with clause 3.3(5); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘“Disclosure: Financial Interests and Arrangements of Clinical Investigators”) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the Clinical Investigation Plan are approved by the Reviewing HREC and Sponsor prior to implementation of the amendment; ensures that the Sponsor’s prior written consent and the approval of the Reviewing HREC are obtained to any advertisement in respect of the Study; provides the Sponsor with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the Sponsor may direct the Institution to cease recruitment; is available when a clinical research representative of the Sponsor visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the Sponsor, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the Clinical Investigation Plan, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the Sponsor; provides regular written progress reports to the Sponsor in relation to the Study as required by the Clinical Investigation Plan; completes and returns to the Sponsor as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the Sponsor, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the ~~Investigational~~ Study Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, ~~Investigational~~ Study Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the ~~Investigational~~ Study Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the ~~Investigational~~ Study Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, ~~the Investigator’s Brochure and~~ with all current and relevant information, including the Instructions for use, regarding the ~~Investigational~~ Study Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the ~~Investigational~~ Study Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the ~~Investigational~~ Study Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary ~~Investigational~~ Study Product accountability forms. The Sponsor ~~must provide~~ indemnifies the Institution against any claim or proceeding that is made, threatened or commenced, and any cost, liability, loss, damage or expense (including reasonable legal and other professional costs on a full indemnity basis) (Liability) that the Institution incurs or suffers, as a result of: a negligent or wrongful act or omission of the Sponsor; or a breach of Relevant Privacy Laws by the Sponsor; However, the Sponsor is not required to indemnify the Institution to the ~~Institution and members~~ extent that the Liability results directly from a negligent or wrongful act or omission of the ~~Reviewing HREC against claims arising from~~ Institution, or its Personnel, a breach of this Agreement or a failure to follow the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5Protocol. The Sponsor must maintain at all times policies of insurance ~~with respect~~ in relation to its ~~activities~~ business against such risks as are normally insured by prudent companies carrying on a similar business and ~~indemnity obligations~~ to cover all claims or damages for which it may be liable under this Agreement ~~in accordance with Schedule 4. This insurance~~ or as is ~~to be evidenced by a certificate of insurance, as requested~~ reasonably required by the Institution from time to time. The Sponsor must, within a reasonable time of a written request to do so, deliver to the Institution evidence satisfactory to the Institution that it has an appropriate and current insurance policy (or policies).

Appears in 1 contract

Samples: Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and ~~responsibilities~~ Responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the ~~Reviewing HREC~~ Responsible EC and the Institution prior to Study initiation. Written documentation of approval by the ~~Reviewing HREC~~ Responsible EC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the ~~Reviewing HREC~~ Responsible EC (as applicable) in accordance with 2.3, and ~~Sponsor~~ the CRG has consented to the amendment in writing prior to implementation of the amendment; ensures that ~~the Sponsor’s~~ prior written ~~consent~~ approval is obtained from the CRG and the ~~approval of the Reviewing HREC are obtained to~~ Responsible EC for any advertisement in respect of the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; ~~notifies~~ Notifies the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC~~ Responsible EC (as applicable) of any Adverse Events (including Serious Adverse Events) ~~that occur during the course of the Study~~ in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the ~~Reviewing HREC~~ Responsible EC, with their policies and procedures; completes Case Report Forms within the agreed time period, as described in Schedule 4. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant ~~prior to their enrolment~~ in accordance with the ~~Study~~ informed consent process approved by the Responsible EC and is documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC, provided however that where a Study Participant~~ Responsible EC; as soon as is ~~unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements~~ practical advises the CRG if the Responsible EC alters its approval of the ~~Reviewing HREC.~~ Study; Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must Notify the CRG as soon as is practical; the Institution must consult with the ~~Sponsor~~ CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both ~~parties~~Parties; and if a replacement cannot be found who is acceptable to both Parties, the ~~Sponsor~~ CRG may require recruitment into the Study by the Institution to cease, ~~or move~~ and the ~~Study to a different Study Site~~CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (54), (8)7), (9), (10), (1112), (~~13)~~ 14), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, ~~it and~~ it, its affiliates and any ~~other~~ person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory ~~Authority~~Authority for debarment. Furthermore, the Institution shall ~~notify~~ Notify the ~~Sponsor~~ CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution ~~will not~~ must not, and must ensure that its Personnel involved in the conduct of the Study do not, engage in any conduct on the ~~Sponsor~~CRG’s behalf which is in violation of, or potentially in violation of, any applicable ~~local or foreign~~ New Zealand laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits to the Study Site in accordance with ~~Clinical Investigation Plan~~the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the ~~Clinical Investigation Plan,~~ Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study ~~Materials~~ related materials and its Personnel as soon as is reasonably possible upon request by the ~~Sponsor~~CRG, Regulatory Authority, ~~Reviewing HREC~~ Responsible EC or any third party reasonably designated by the ~~Sponsor~~CRG. Any such access is to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the ~~Clinical Investigation Plan~~Protocol, provided that any amendments to the ~~Clinical Investigation Plan~~ Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the ~~Reviewing HREC~~Responsible EC (as applicable). The Institution will have an adequate number of appropriately qualified Personnel ~~available for the Study~~ for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the ~~Clinical Investigation Plan~~Protocol, Investigational ~~Product(s)~~Product, and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, ~~Clinical Investigation Plan~~Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of ~~Sponsor~~CRG. The Institution agrees to ~~notify~~ Notify the ~~Sponsor~~ CRG before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the ~~Sponsor~~ CRG at the ~~Sponsor~~CRG’s expense. The Institution ~~must~~ will ensure that the Study is subject to the continuing oversight of the ~~Reviewing HREC~~ Responsible EC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately ~~notify~~ Notify the ~~Sponsor~~CRG, unless prevented from doing so by law. The Institution ~~must~~ will provide the ~~Sponsor~~ CRG with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit or inspection of the Institution or Study Site. This includes execution of any documents reasonably requested by the ~~Sponsor~~ CRG in connection with the requirements of a Regulatory Authority or the ~~Sponsor~~ CRG as a result of such an ~~audit~~audit or inspection. ~~The cost will~~ Any costs resulting from such audit shall be borne equally by the ~~Sponsor~~ Parties, unless ~~such rectification is due to~~ the ~~default~~ cost has resulted solely from an act or omission of a Party, in which case that Party will bear the ~~Institution or the Principal Investigator~~total costs. The Institution shall obtain approval, in writing, from the ~~Sponsor~~ CRG for any ~~press~~ media statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. ~~Sponsor~~ The Institution is responsible for ensuring that the Principal Investigator has a robust procedure in place prior to the commencement of the Study, for the review of all safety information (whether internal or provided by the CRG) by appropriately qualified members of the Study staff. The Institution agrees to listing of trial particulars, including Investigator name and site address, as may be required by law, on reputable clinical trial registries (e.g. xxxxxxxxxxxxxx.xxx). CRG Obligations and ~~responsibilities~~ Responsibilities CRG warrants that it has the capacity and the authority to enter into this Agreement and to perform its obligations under this Agreement. The body of this Agreement must be in identical form to the current standard templated form located at xxx.xxxxxxx.xxx.xx. Any textual changes to the body of this Agreement from the templated version will not be valid. The clauses of this Agreement can only be changed by way of Special Conditions documented within Schedule 5. Where there is a conflict between the main body of this Agreement and the Special Conditions, the Special Conditions shall prevail. Prior to the Agreement being executed, the ~~Sponsor must~~ CRG or its designate will provide the Principal Investigator, and through the Principal Investigator the Institution and the ~~Reviewing HREC~~Responsible EC, ~~the Investigator’s Brochure and~~ with all current and relevant ~~information, including the Instructions for use,~~ information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The ~~Sponsor must~~ CRG or its designee will act as the applicant for the purposes of an application for approval of a clinical trial under Section 30 of the Medicines Act. The CRG or designee is responsible for ensuring the preparation and submission of all documents required by Medsafe for initiating and conducting the study. The CRG will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The ~~Sponsor must~~ CRG will designate appropriately qualified ~~personnel~~ Personnel to advise on Study-related medical questions or problems. The ~~Sponsor must~~ CRG will monitor the application of the Investigational Product in other places (both within and outside ~~Australia)~~ New Zealand as applicable), and advise the Institution, through the Principal Investigator and ~~TGA~~ Medsafe, of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The ~~Sponsor must notify~~ CRG will Notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The ~~Sponsor must~~ CRG will cooperate with the Institution and/or the ~~Reviewing HREC~~ Responsible EC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the ~~Sponsor must~~ CRG will provide the Institution with adequate information and all necessary Investigational Product accountability forms. The ~~Sponsor must provide indemnity to~~ CRG warrants that the ~~Institution and members~~ Study is not being conducted principally for the benefit of the ~~Reviewing HREC against claims arising from~~ Manufacturer or distributor of the Investigational Product in respect of which the trial is being carried out. The CRG will register the Study on the ~~terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity~~ appropriate clinical trial registry or registries (for ~~Clinical Investigations as set out in Schedule 3~~example; xxxxxxxxxxxxxx.xxx or ANZCTR). The ~~Sponsor will comply~~ CRG further warrant that the information submitted to the Responsible EC is accurate and complete and that the nature of the relationship with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities Investigational Product Manufacturer is fully and ~~indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time~~accurately disclosed.

Appears in 1 contract

Samples: Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and ~~responsibilities~~ Responsibilities The Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the ~~Reviewing HREC~~ Responsible EC and the Institution prior to Study initiation. Written documentation of approval by the ~~Reviewing HREC~~ Responsible EC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the ~~Reviewing HREC~~ Responsible EC (as applicable) in accordance with 2.3, and ~~Sponsor~~ the CRG has consented to the amendment in writing prior to implementation of the amendment; ensures that ~~the Sponsor’s~~ prior written ~~consent~~ approval is obtained from the CRG and the ~~approval of the Reviewing HREC are obtained to~~ Responsible EC for any advertisement in respect of the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; ~~notifies~~ Notifies the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC~~ Responsible EC (as applicable) of any Adverse Events (including Serious Adverse Events) ~~that occur during the course of the Study~~ in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the ~~Reviewing HREC~~ Responsible EC, with their policies and procedures; completes Case Report Forms within the agreed time period, as described in Schedule 4. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; and ensures that informed consent to participate in the Study is obtained from each Study Participant ~~prior to their enrolment~~ in accordance with the ~~Study~~ informed consent process approved by the Responsible EC and is documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the ~~Reviewing HREC, provided however that where a Study Participant~~ Responsible EC; as soon as is ~~unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements~~ practical advises the CRG if the Responsible EC alters its approval of the ~~Reviewing HREC.~~ Study; Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must Notify the CRG as soon as is practical; the Institution must consult with the ~~Sponsor~~ CRG and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both ~~parties~~Parties; and if a replacement cannot be found who is acceptable to both Parties, the ~~Sponsor~~ CRG may require recruitment into the Study by the Institution to cease, ~~or move~~ and the ~~Study to a different Study Site~~CRG may terminate this Agreement in accordance with clause 14.4. If the Principal Investigator fails to carry out those obligations specified in clauses ~~3.3(2~~3.3(21), (332), (54), (8)87), (9), (10), (11112), (~~13)~~ 143), or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, ~~it and~~ it, its affiliates and any ~~other~~ person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory ~~Authority~~Authority for debarment. Furthermore, the Institution shall ~~notify~~ Notify the ~~Sponsor~~ CRG as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution ~~will not~~ must not, and must ensure that its Personnel involved in the conduct of the Study do not, engage in any conduct on the ~~Sponsor~~CRG’s behalf which is in violation of, or potentially in violation of, any applicable ~~local or foreign~~ New Zealand laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits to the Study Site in accordance with ~~Clinical Investigation Plan~~the GCP Guideline, access for the purposes of audit and as required by Regulatory Authorities or as specified in the ~~Clinical Investigation Plan,~~ Protocol and permit access to the Essential Documents (including original records), Study records, reports, other Study ~~Materials~~ related materials and its Personnel as soon as is reasonably possible upon request by the ~~Sponsor~~CRG, Regulatory Authority, ~~Reviewing HREC~~ Responsible EC or any third party reasonably designated by the ~~Sponsor~~CRG. Any such access is to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the ~~Clinical Investigation Plan~~Protocol, provided that any amendments to the ~~Clinical Investigation Plan~~ Protocol which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the ~~Reviewing HREC~~Responsible EC (as applicable). The Institution will have an adequate number of appropriately qualified Personnel ~~available for the Study~~ for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the ~~Clinical Investigation Plan~~Protocol, Investigational ~~Product(s)~~Product, and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, ~~Clinical Investigation Plan~~Protocol, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of ~~Sponsor~~CRG. The Institution agrees to ~~notify~~ Notify the ~~Sponsor~~ CRG before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the ~~Sponsor~~ CRG at the ~~Sponsor~~CRG’s expense. The Institution ~~must~~ will ensure that the Study is subject to the continuing oversight of the ~~Reviewing HREC~~ Responsible EC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately ~~notify~~ Notify the ~~Sponsor~~CRG, unless prevented from doing so by law. The Institution ~~must~~ will provide the ~~Sponsor~~ CRG with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit or inspection of the Institution or Study Site. This includes execution of any documents reasonably requested by the ~~Sponsor~~ CRG in connection with the requirements of a Regulatory Authority or the ~~Sponsor~~ CRG as a result of such an ~~audit~~audit or inspection. ~~The cost will~~ Any costs resulting from such audit shall be borne equally by the ~~Sponsor~~ Parties, unless ~~such rectification is due to~~ the ~~default~~ cost has resulted solely from an act or omission of a Party, in which case that Party will bear the ~~Institution or the Principal Investigator~~total costs. The Institution shall obtain approval, in writing, from the ~~Sponsor~~ CRG for any ~~press~~ media statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. ~~Sponsor~~ The Institution is responsible for ensuring that the Principal Investigator has a robust procedure in place prior to the commencement of the Study, for the review of all safety information (whether internal or provided by the CRG) by appropriately qualified members of the Study staff. The Institution agrees to listing of trial particulars, including Investigator name and site address, as may be required by law, on reputable clinical trial registries (e.g. xxxxxxxxxxxxxx.xxx). CRG Obligations and ~~responsibilities~~ Responsibilities CRG warrants that it has the capacity and the authority to enter into this Agreement and to perform its obligations under this Agreement. The body of this Agreement must be in identical form to the current standard templated form located at xxx.xxxxxxx.xxx.xx. Any textual changes to the body of this Agreement from the templated version will not be valid. The clauses of this Agreement can only be changed by way of Special Conditions documented within Schedule 5. Where there is a conflict between the main body of this Agreement and the Special Conditions, the Special Conditions shall prevail. Prior to the Agreement being executed, the ~~Sponsor must~~ CRG or its designate will provide the Principal Investigator, and through the Principal Investigator the Institution and the ~~Reviewing HREC~~Responsible EC, ~~the Investigator’s Brochure and~~ with all current and relevant ~~information, including the Instructions for use,~~ information regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The ~~Sponsor must~~ CRG or its designee will act as the applicant for the purposes of an application for approval of a clinical trial under Section 30 of the Medicines Act. The CRG or designee is responsible for ensuring the preparation and submission of all documents required by Medsafe for initiating and conducting the study. The CRG will implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The ~~Sponsor must~~ CRG will designate appropriately qualified ~~personnel~~ Personnel to advise on Study-related medical questions or problems. The ~~Sponsor must~~ CRG will monitor the application of the Investigational Product in other places (both within and outside ~~Australia)~~ New Zealand as applicable), and advise the Institution, through the Principal Investigator and ~~TGA~~ Medsafe, of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The ~~Sponsor must notify~~ CRG will Notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The ~~Sponsor must~~ CRG will cooperate with the Institution and/or the ~~Reviewing HREC~~ Responsible EC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the ~~Sponsor must~~ CRG will provide the Institution with adequate information and all necessary Investigational Product accountability forms. The ~~Sponsor must provide indemnity to~~ CRG warrants that the ~~Institution and members~~ Study is not being conducted principally for the benefit of the ~~Reviewing HREC against claims arising from~~ Manufacturer or distributor of the Investigational Product in respect of which the trial is being carried out. The CRG will register the Study on the ~~terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity~~ appropriate clinical trial registry or registries (for ~~Clinical Investigations as set out in Schedule 3~~example; xxxxxxxxxxxxxx.xxx or ANZCTR). The ~~Sponsor will comply~~ CRG further warrant that the information submitted to the Responsible EC is accurate and complete and that the nature of the relationship with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities Investigational Product Manufacturer is fully and ~~indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time~~accurately disclosed.

Appears in 1 contract

Samples: Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRIG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities ~~The~~ Without limiting any other obligations the Institution has under this Agreement or at law, the Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRIG; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the ~~Sponsor~~CRIG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRIG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and ~~Sponsor~~ CRIG prior to implementation of the amendment; ~~ensures that~~ as soon as is practical advises the ~~Sponsor’s prior written consent and~~ CRIG if the Responsible HREC alters its approval of the ~~Reviewing~~ Study; obtains prior written approval from the CRIG and the Responsible HREC ~~are obtained~~ of any proposed advertisements to ~~any advertisement~~ be used for the purpose of Study Participant recruitment in ~~respect of~~ the Study; provides the ~~Sponsor~~ CRIG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRIG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRIG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the ~~Sponsor~~CRIG, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; ~~completes Case Report Forms within~~ registers the ~~agreed time period. The Principal Investigator will ensure that~~ Study ~~Participants’ identifying information are removed from all records being transferred to~~ on the ~~Sponsor~~appropriate clinical trials registry; provides regular written progress reports to the ~~Sponsor~~ CRIG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRIG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; ~~and~~ ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRIG, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

Appears in 1 contract

Samples: Research Agreement

Liability for Principal Investigator. For the purpose of this Agreement only, and as between the ~~Sponsor~~ CRG and the Institution only, the Institution agrees to be responsible for the acts and omissions of the Principal Investigator in relation to the conduct of the Study, to the extent that such responsibility would attach to the Institution in accordance with its obligations under this Agreement or under the common law on the basis that the Principal Investigator is acting as an employee of the Institution. Nothing in this clause or Agreement affects any pre-existing contractual or other arrangement which may be in place between the Institution and the Principal Investigator. Obligations and responsibilities ~~The~~ Without limiting any other obligations the Institution has under this Agreement or at law, the Institution is responsible for ensuring that the Principal Investigator: thoroughly familiarises himself or herself with the appropriate use of the Investigational Product(s), ~~including the Instructions for use,~~ as described in the ~~Clinical Investigation Plan~~Protocol, Investigator’s Brochure, information relating to the Investigational Product and any other information sources provided by the ~~Sponsor~~CRG; ensures written approval has been obtained to conduct the Study from the Reviewing HREC and the Institution prior to Study initiation. Written documentation of approval by the Reviewing HREC and the Institution must be provided to the ~~Sponsor~~CRG; conducts the Study according to the ~~Clinical Investigation Plan~~ Protocol without ~~changes~~ changes, except as provided in clause 2.2 or 2.3, or as agreed to in writing by the ~~Sponsor~~ CRG and the Institution and approved in accordance with clause ~~3.3(5~~3.3(4); completes (and obtains completion from relevant Personnel) and returns to the Sponsor a statement of financial disclosure (an example that meets this requirement is Food and Drug Administration Form 3455 ‘Disclosure: Financial Interests and Arrangements of Clinical Investigators) before the commencement of the Study and as otherwise required and consents to the disclosure of the completed form to overseas regulatory agencies, if required; ensures that any amendments to the ~~Clinical Investigation Plan~~ Protocol are approved by the Reviewing HREC and ~~Sponsor~~ CRG prior to implementation of the amendment; ~~ensures that~~ as soon as is practical advises the ~~Sponsor’s prior written consent and~~ CRG if the Responsible HREC alters its approval of the ~~Reviewing~~ Study; obtains prior written approval from the CRG and the Responsible HREC ~~are obtained~~ of any proposed advertisements to ~~any advertisement~~ be used for the purpose of Study Participant recruitment in ~~respect of~~ the Study; provides the ~~Sponsor~~ CRG with evidence of the Principal Investigator’s qualifications through a current curriculum vitae and/or other relevant documentation and a list of appropriately qualified persons to whom they have delegated significant Study-related duties, if required; uses his or her best endeavours to recruit the target number of Study Participants, within the recruitment period, specified in Schedule 1, provided that if the overall target number of Study Participants for the Study is reached, the ~~Sponsor~~ CRG may direct the Institution to cease recruitment; is available when a clinical research representative of the ~~Sponsor~~ CRG visits the Study Site, as mutually agreed prior to the visit, and is contactable by telephone or electronic mail as frequently as is reasonably required; notifies the ~~Sponsor~~CRG, the Institution and the Reviewing HREC of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study in accordance with the ~~Clinical Investigation Plan~~Protocol, and relevant ethical and regulatory guidelines, and in the case of the Institution and the Reviewing HREC with their policies and procedures; completes Case Report Forms within the agreed time period. The Principal Investigator will ensure that Study Participants’ identifying information are removed from all records being transferred to the ~~Sponsor~~CRG; provides regular written progress reports to the ~~Sponsor~~ CRG in relation to the Study as required by the ~~Clinical Investigation Plan~~Protocol; completes and returns to the ~~Sponsor~~ CRG as required any Study related materials within a reasonable time period; is not subject to any obligations, either contractually or in any other way, which would unreasonably interfere with or prohibit the performance of work related to this Study; ~~and~~ ensures that informed consent to participate in the Study is obtained from each Study Participant prior to their enrolment in the Study and documented using an information and consent document which has been reviewed and approved by the ~~Sponsor~~CRG, the Institution and the Reviewing HREC, provided however that where a Study Participant is unable to give informed consent, that Study Participant is enrolled in accordance with all applicable legislative requirements as well as any requirements of the Reviewing HREC. Institution Obligations and Responsibilities If the Principal Investigator leaves the Institution or otherwise ceases to be available then: the Institution must consult with the Sponsor and use reasonable endeavours to nominate as soon as practicable a replacement reasonably acceptable to both parties; and the Sponsor may require recruitment into the Study by the Institution to cease, or move the Study to a different Study Site. If the Principal Investigator fails to carry out those obligations specified in clauses 3.3(2), (3), (5), (8), (10), (11), (13) or (15), then the Institution must itself perform those obligations and rectify and make good any breach. The Institution will ensure that any Personnel who assist in the conduct of the Study are informed of and agree to abide by all terms of this Agreement relevant to the activities they perform. The Institution warrants that to the best of its knowledge, it and its affiliates and any other person involved in the conduct of the Study, including the Principal Investigator, are properly registered with appropriate professional registration bodies, have not been disqualified from practice or disbarred or banned from conducting clinical trials by any Regulatory Authority. Furthermore, the Institution shall notify the Sponsor as soon as practical after it becomes aware of any such disqualification, disbarment or ban. The Institution will not engage in any conduct on the Sponsor’s behalf which is in violation of, or potentially in violation of, any applicable local or foreign laws or regulations. The Institution warrants, represents and undertakes to the Sponsor that it has not offered, promised or paid, either directly or indirectly, any Benefit to a government official (including, but not limited to, a healthcare professional employed by a government-owned healthcare facility) to induce such government official to act in any way in connection with his or her official duties with respect to services performed under this Agreement or to otherwise obtain an improper advantage for the Institution or the Sponsor (Improper Payment), and has not received an Improper Payment, and will not offer, promise, pay, authorise or receive any Improper Payment in the future. For the purposes of the foregoing, Benefit includes but is not limited to money, financial or other advantage, travel expenses, entertainment, business or investment opportunities, charitable donations or any other thing of value. The Institution must have adequate security measures to ensure the safety and integrity of the Investigational Product, Essential Documents and Study records and reports, Equipment and any Study related materials held or located at the Study Site. Subject to clause 9, the Institution will allow regular monitoring visits in accordance with Clinical Investigation Plan, access for the purposes of audit as required by Regulatory Authorities or as specified in the Clinical Investigation Plan, permit access to the Essential Documents (including original records), Study records, reports, other Study Materials and its Personnel as soon as is reasonably possible upon request by the Sponsor, Regulatory Authority, Reviewing HREC or any third party designated by the Sponsor. Any such access to take place at times mutually agreed during business hours and subject to such reasonable conditions relating to occupational health and safety, security, and confidentiality as the Institution may require. The Institution will make available adequate facilities, equipment and any other resource of the Institution reasonably required to safely follow the Clinical Investigation Plan, provided that any amendments to the Clinical Investigation Plan which take place after the execution of this Agreement and requiring any additional use of facilities, equipment, staff or resources, have been approved in writing by the Institution and the Reviewing HREC. The Institution will have an adequate number of appropriately qualified Personnel available for the Study for the foreseen duration of the Study and ensure that such Personnel are adequately informed about the Clinical Investigation Plan, Investigational Product(s), and their Study related duties and functions. The Personnel appointed by the Institution to assess Study Participants will attend an investigator meeting or a pre-study/initiation meeting, where appropriate. The Institution must retain and preserve a copy of all Study Materials, including copies of signed consent forms, Case Report Forms, Clinical Investigation Plan, information relating to the Investigational Product, correspondence and investigator files for at least 15 years from Study Completion and must ensure that no Study related materials are destroyed before the expiration of this time period without the written approval of Sponsor. The Institution agrees to notify the Sponsor before destroying any Study Materials and agrees to retain the Study Materials for such longer period as reasonably required by the Sponsor at the Sponsor’s expense. The Institution must ensure that the Study is subject to the continuing oversight of the Reviewing HREC throughout its conduct. If the Institution is contacted by any Regulatory Authority in connection with the conduct of the Study, the Institution shall immediately notify the Sponsor, unless prevented from doing so by law. The Institution must provide the Sponsor with all reasonable assistance and cooperation to rectify any matter raised by a Regulatory Authority or as the result of an audit of the Institution or Study Site. This includes execution of any documents reasonably requested by the Sponsor in connection with the requirements of a Regulatory Authority or the Sponsor as a result of such an audit. The cost will be borne by the Sponsor unless such rectification is due to the default of the Institution or the Principal Investigator. The Institution shall obtain approval, in writing, from the Sponsor for any press statements or promotional statements regarding the Study or the Investigational Product(s) before the statements are released, unless the statement or disclosure is required by: law; any policy, guideline or direction of government or any government department or agency; any Regulatory Authority; or is, in the absolute discretion of the Institution, Minister for Health, Department of Health or any government official, reasonably necessary in the public interest or to protect the health and safety of any individual. Sponsor Obligations and responsibilities Prior to the Agreement being executed, the Sponsor must provide the Principal Investigator, and through the Principal Investigator the Institution and the Reviewing HREC, the Investigator’s Brochure and all current and relevant information, including the Instructions for use, regarding the Investigational Product as reasonably required to justify the nature, scope and duration of the Study. The Sponsor must implement and maintain quality assurance and quality control systems with written standard operating procedures to ensure that the Study can be conducted and data generated, documented, recorded and reported in compliance with all of the documents referred to in clause 2.1. The Sponsor must designate appropriately qualified personnel to advise on Study-related medical questions or problems. The Sponsor must monitor the application of the Investigational Product in other places (both within and outside Australia) and advise the Institution, through the Principal Investigator and TGA of the cessation elsewhere of any relevant trial, or the withdrawal of the Investigational Product from any other market for safety reasons. The Sponsor must notify the Institution of any Adverse Events (including Serious Adverse Events) that occur during the course of the Study (either at the Study Site or other study sites, including overseas sites) which may require alteration of the conduct of the Study, or which may affect the rights, interests, safety or well-being of Study Participants. The Sponsor must cooperate with the Institution and/or the Reviewing HREC in investigating any Adverse Event (including Serious Adverse Event) arising out of or in connection with the Study. To assist the Institution to comply with clause 8, the Sponsor must provide the Institution with adequate information and all necessary Investigational Product accountability forms. The Sponsor must provide indemnity to the Institution and members of the Reviewing HREC against claims arising from the Study on the terms and conditions set out in the relevant Medical Technology Association of Australia Form of Indemnity for Clinical Investigations as set out in Schedule 3. The Sponsor will comply with the Medical Technology Association of Australia Guidelines for Compensation for Injury Resulting from Participation in a Company-sponsored clinical investigation as specified in Schedule 5. The Sponsor must maintain insurance with respect to its activities and indemnity obligations under this Agreement in accordance with Schedule 4. This insurance is to be evidenced by a certificate of insurance, as requested by the Institution from time to time.

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Common use of Liability for Principal Investigator Clause in Contracts