Safety and Monitoring Issues Sample Clauses

Safety and Monitoring Issues. Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval Before award and then with the annual progress report, the Contractor must submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number. The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:
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Safety and Monitoring Issues. 1. Institutional Review Board or Independent Ethics Committee Approval Within [***] of award and then with the annual progress report, the Contractor must submit to the COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide number. The Contractor must ensure that the application as well as all protocols is reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the COR copies of documents related to all major changes in the status of ongoing protocols, including the following:  All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid.  All changes in informed consent documents, identified by version number, dates, or both and dates it is valid.  Termination or temporary suspension of patient accrual.  Termination or temporary suspension of the protocol.  Any change in IRB approval.  Any other problems or issues that could affect the participants in the studies. The Contractor must notify the COR and CO of any of the above changes within [***] by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Safety and Monitoring Issues i. Institutional Review Board or Independent Ethics Committee Approval Within 30 days of award and then with the annual progress report, the Contractor must submit to the COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol or have formally accepted the review of a central IRB/IEC. They must also provide BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document or federal wide assurance number. The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC or a formally recognized central IRB/IEC. To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the COR copies of documents related to all major changes in the status of ongoing protocols, including the following: • All amendments or changes to the protocol, identified by protocol version number, date, or both and dates it is valid. • All changes in informed consent documents, identified by version number, dates, or both and dates it is valid. • Termination or temporary suspension of patient accrual. • Termination or temporary suspension of the protocol. • Any change in IRB approval. • Any other problems or issues that could affect the participants in the studies. The Contractor must notify the COR and CO of any of the above changes within five (5) working days by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC. If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.
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Safety and Monitoring Issues i. Institutional Review Board or Independent Ethics Committee Approval Before initiating enrollment of subjects then with the annual progress report, the Contractor must submit to the CO and COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site. If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s IRB or IEC must review and approve the protocol. They must also provide the CO and the COR initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide assurance number. The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC or that of the CRO to which the contractor assigns the responsibility. Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Safety and Monitoring Issues 
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Related to Safety and Monitoring Issues

  • Safety and Compliance The Company commits to make all management and employees aware of all the changes to the Occupational Health and Safety Act and Regulations. This should be done via training courses and or union seminars. The conducting of the training and or seminars shall be at times convenient to the company.

  • WORKPLACE SAFETY AND INSURANCE 41.1 Where an employee is absent by reason of an injury or an occupational disease for which a claim is made under the Workplace Safety and Insurance Act, his or her salary shall continue to be paid for a period not exceeding thirty (30) days. If an award is not made, any payments made under the foregoing provisions in excess of that to which he or she is entitled under Articles 44.1 and 44.6 (Short Term Sickness Plan) shall be an amount owing by the employee to the Employer.

  • Labor-Management Cooperation When an Appointing Authority initiates a planning process or management study which is anticipated to result in layoff, the Appointing Authority will meet and confer with the Local Union during the decision planning phase and again during the implementation planning phase. The Appointing Authority and the Local Union shall enter into negotiations regarding a Memoranda of Understanding upon request of either party to modify this Agreement regarding the implementation plans which shall include, but are not limited to, the following: • Length of layoff notice; • Job and retraining opportunities; • Alternative placement methods; • Early retirement options pursuant to M.S. 43A.24, Subd. 2(i); • Bumping/vacancy options for part-time employees to preserve their insurance eligibility or contribution; and • Other methods of mitigating layoff or their effect on employees.

  • Public safety compliance The Hirer shall comply with all conditions and regulations made in respect of the premises by the Fire Authority, Local Authority, the Licensing Authority or otherwise, particularly in connection with any event which constitutes regulated entertainment, at which alcohol is sold or provided or which is attended by children.

  • Safety Boots Each employee, after 3 months’ continuous service, will be reimbursed (on production of a receipt), the cost of one pair of safety boots (approved by the employer), in each year, to a maximum of $110.00. Wet Weather All protective clothing such as wet weather jackets, safety helmets, welding jackets, welding xxxxxxx, welding gauntlets, rubber boots, etc, (which remain the property of the Company), will be supplied on all occasions deemed necessary.

  • COMPLIANCE WITH HEALTH, SAFETY, AND ENVIRONMENTAL REGULATIONS The Contractor, it’s Subcontractors, and their respective employees, shall comply fully with all applicable federal, state, and local health, safety, and environmental laws, ordinances, rules and regulations in the performance of the services, including but not limited to those promulgated by the City and by the Occupational Safety and Health Administration (OSHA). In case of conflict, the most stringent safety requirement shall govern. The Contractor shall indemnify and hold the City harmless from and against all claims, demands, suits, actions, judgments, fines, penalties and liability of every kind arising from the breach of the Contractor’s obligations under this paragraph.

  • Safety and Security Procedures Contractor shall maintain and enforce, at the Contractor Work Locations, industry-standard safety and physical security policies and procedures. While at each Court Work Location, Contractor shall comply with the safety and security policies and procedures in effect at such Court Work Location.

  • Health, Safety and Environment 41.1 In the performance of this Contract, Contractor and Operator shall conduct Petroleum Operations with due regard to health, safety and the protection of the environment (“HSE”) and the conservation of natural resources, and shall in particular:

  • OCCUPATIONAL SAFETY AND HEALTH Section 1. The Labor-Management Committee established pursuant to Article XVI shall sit from time to time as an Occupational Safety and Health Committee.

  • Safety and Protection 8.18.1 The Contractor shall be responsible for initiating, maintaining and supervising all safety precautions and programs in connection with the Work. The Contractor shall take all necessary precautions for the safety of, and shall provide the necessary protection to prevent damage, injury or loss to:

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