Study Review Sample Clauses

Study Review. KFSH&RC-J shall conduct the Study at the KFSH&RC-J facilities with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. KFSH&RC-J shall provide SPONSOR with written evidence of review and approval of this Study by KFSH&RC-J Institutional Review Board (“IRB”) prior to the initiation of the Study and shall inform SPONSOR of the IRB’s continuing review promptly after such a review takes place, which shall be at least once per year.
Sample 1
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Study Review. The PI shall conduct the STUDY at the KFSH&RC facilities with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable local laws and regulations. PI shall obtain approval of this STUDY from the KFSH&RC Research Ethics Committee (“REC”) prior to initiation of the STUDY. Written evidence of review and approval of the STUDY by the KFSH&RC REC shall be maintained by PI and be made available to the Kingdom of Saudi Arabia’s Food and Drug Authority upon request. Continuing review by REC shall take place at least once per year, and documentation of continuing approval shall be maintained by PI.
Sample 1
Study Review. The Study shall be conducted by staff members of Institution under the direction of the Principal Investigator at Institution or elsewhere with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. The Study may also be subcontracted to other sites which have been approved by deCODE ("Approved Subcontractee"), provided that any such Approved Subcontractee agrees in writing to be bound by the terms of this Agreement. Principal Investigator shall provide deCODE with written evidence of review and approval of this Study by Institution's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform deCODE of the IRB's continuing review promptly after such review takes place, which shall be at least once per year.
Sample 1
Study Review. Principal Investigator shall conduct the Study at General with the prior approval and ongoing review, of all appropriate and necessary review authorities and in accordance with all applicable federal, state, and local laws. and regulations. Principal Investigator shall provide Company with written evidence of review and approval of this Study by General's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform Company of the IRB's continuing review promptly after such review takes place, which shall be at least once per year. All volunteers shall meet the legal age requirements of the Commonwealth of Massachusetts, the state in which the Study is to be conducted.
Sample 1
Study Review. Research conducted by the Principal Investigator at General shall be with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. Principal Investigator shall, when applicable, provide Palomar with written evidence of review and approval of Clinical Studies prior to initiation of the Clinical Studies and shall inform Palomar of the IRB’s continuing review promptly after such review takes place, which shall be at least once per year. All volunteers shall meet the legal age requirements of the Commonwealth of Massachusetts, the state in which the Research is to be conducted. In the performance of this Agreement, General agrees not to provide Palomar with any patient identifying information. Recognizing a common goal of securing the integrity of all individually identifiable health information, the parties agree to treat as confidential all individually identifiable health information in accordance with all applicable federal, state and local laws, rules and regulations governing the confidentiality and privacy of individually identifiable health information, including, but without limitation, to the extent that each party is subject to it, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and any regulations and official guidance promulgated thereunder. Palomar further agrees, at all times, to regard and preserve as confidential such individually identifiable health information, and to refrain from publishing or disclosing any part of such individually identifiable health information or from using it, except as necessary to discuss and analyze the results of the study, to ensure research integrity, to communicate with the Food and Drug Administration and other regulatory authorities, and otherwise as required by law or as permitted by authorizations or consents signed by study subjects or waivers of authorization granted by an IRB overseeing the study or General’s affiliated Privacy Board (the “Permitted Activities”). Palomar also agrees to restrict the use and disclosure of any individually identifiable health information gained through the Permitted Activities to its workforce, contractors, subcontractors, study collaborators and agents (collectively “Recipients of Patient Information”) who must have access to that information in order directly to support or facilitate the Permitted Activities; and to notify the Rec...
Sample 1
Study Review. DFPCC shall conduct the Study with the prior approval and ongoing review of all appropriate and necessary review authorities and in accordance with all applicable federal, state and local laws and regulations. Principal Investigator shall provide Company with written evidence of review and approval of this Study by DFPCC's Institutional Review Board ("IRB") prior to the initiation of the Study and shall inform Company of the IRB's continuing review and approval of the Study promptly after such review takes place, which shall be at least once per year.
Sample 1
Study Review. Both cities shall have the opportunity to participate in the Feasibility Study review and provide comments on all deliverables. The cities agree to conduct the reviews and provide comments in a timely manner to assist the consultant in completing the Feasibility Study on the timeline designated in the contract.
Sample 1
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Related to Study Review

  • Independent Review Contractor shall provide the Secretary of ADS/CIO an independent expert review of any Agency recommendation for any information technology activity when its total cost is $1,000,000.00 or greater or when CIO requires one. The State has identified two sub-categories for Independent Reviews, Standard and Complex. The State will identify in the SOW RFP the sub-category they are seeking. State shall not consider bids greater than the maximum value indicated below for this category. Standard Independent Review $25,000 Maximum Complex Independent Review $50,000 Maximum Per Vermont statute 3 V.S.A. 2222, The Secretary of Administration shall obtain independent expert review of any recommendation for any information technology initiated after July 1, 1996, as information technology activity is defined by subdivision (a) (10), when its total cost is $1,000,000 or greater or when required by the State Chief Information Officer. Documentation of this independent review shall be included when plans are submitted for review pursuant to subdivisions (a)(9) and (10) of this section. The independent review shall include: • An acquisition cost assessment • A technology architecture review • An implementation plan assessment • A cost analysis and model for benefit analysis • A procurement negotiation advisory services contract • An impact analysis on net operating costs for the agency carrying out the activity In addition, from time to time special reviews of the advisability and feasibility of certain types of IT strategies may be required. Following are Requirements and Capabilities for this Service: • Identify acquisition and lifecycle costs; • Assess wide area network (WAN) and/or local area network (LAN) impact; • Assess risks and/or review technical risk assessments of an IT project including security, data classification(s), subsystem designs, architectures, and computer systems in terms of their impact on costs, benefits, schedule and technical performance; • Assess, evaluate and critically review implementation plans, e.g.: • Adequacy of support for conversion and implementation activities • Adequacy of department and partner staff to provide Project Management • Adequacy of planned testing procedures • Acceptance/readiness of staff • Schedule soundness • Adequacy of training pre and post project • Assess proposed technical architecture to validate conformance to the State’s “strategic direction.” • Insure system use toolsets and strategies are consistent with State Chief Information Officer (CIO) policies, including security and digital records management; • Assess the architecture of the proposed hardware and software with regard to security and systems integration with other applications within the Department, and within the Agency, and existing or planned Enterprise Applications; • Perform cost and schedule risk assessments to support various alternatives to meet mission need, recommend alternative courses of action when one or more interdependent segment(s) or phase(s) experience a delay, and recommend opportunities for new technology insertions; • Assess the architecture of the proposed hardware and software with regard to the state of the art in this technology. • Assess a project’s backup/recovery strategy and the project’s disaster recovery plans for adequacy and conformance to State policy. • Evaluate the ability of a proposed solution to meet the needs for which the solution has been proposed, define the ability of the operational and user staff to integrate this solution into their work.

  • Publicity Review Subject to the further provisions of this Section, no Party shall originate any written publicity, news release, or other announcement or statement relating to this Agreement or to performance hereunder or the existence of an arrangement between the Parties (collectively, "Written Disclosure"), without the prior prompt review and written approval of the other, which approval shall not be unreasonably withheld or delayed. Notwithstanding the foregoing provisions of this Section, any Party may make any public Written Disclosure it believes in good faith based upon the advice of counsel is required by applicable law or any listing or trading agreement concerning its publicly traded securities, provided that prior to making such Written Disclosure, the disclosing Party shall provide the other Party with a copy of the materials proposed to be disclosed and provide the receiving Party with an opportunity to promptly review the proposed Written Disclosure. To the extent that the receiving Party reasonably requests that any information in the materials proposed to be disclosed be deleted, the disclosing Party shall request confidential treatment of such information pursuant to Rule 406 of the Securities Act of 1933 or Rule 26b-2 of the Securities Exchange Act of 1934, as applicable (or any other applicable regulation relating to the confidential treatment of information), so that there be omitted from the materials that are publicly filed any information that the receiving Party reasonably requests to be deleted. The terms of this Agreement may also be disclosed to (i) government agencies where required by law, or (ii) Third Parties with the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, so long as such disclosure is made under a binder of confidentiality and so long as highly sensitive terms and conditions such as financial terms are extracted from the Agreement or not disclosed upon the request of the other Party. All Written Disclosures shall be factual and as brief as is reasonable under the circumstances. Upon request by either Party, the Parties agree to prepare a mutually agreed press release and question and answer document with respect to this Agreement. Each Party agrees that all Written Disclosures and oral statements relating hereto shall be consistent with the answers specified in such question and answer document.

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Periodic Review The General Counsel shall periodically review the Procurement Integrity Procedures with OSC personnel in order to ascertain potential areas of exposure to improper influence and to adopt desirable revisions for more effective avoidance of improper influences.

  • Review The practitioner reviews the treatment plan and discusses, when appropriate, case circumstances and management options with the attending (or referring) physician. The reviewer consults with the requesting physician when more clarity is needed to make an informed coverage decision. The reviewer may consult with board certified physicians from appropriate specialty areas to assist in making determinations of coverage and/or appropriateness. All such consultations will be documented in the review text. If the reviewer determines that the admission, continued stay or service requested is not a covered service, a notice of non-coverage is issued. Only a physician, behavioral health practitioner (such as a psychiatrist, doctoral-level clinical psychologist, certified addiction medicine specialist), dentist or pharmacist who has the clinical expertise appropriate to the request under review with an unrestricted license may deny coverage based on medical necessity.

  • Examination and Review A volunteer, upon presenting identification, shall be permitted by appointment to examine and copy his/her complete County volunteer file, MCFRS operating, or medical record. The volunteer shall indicate in writing, to be placed in his/her file, that he/she has examined the same. The custodian of medical records may determine, consistent with State law, that certain medical information will only be released to the physician or attorney of the volunteer upon receipt of a signed release from the volunteer. Medical records will be maintained in accordance with Section Three of this Article. The County may retain and store records in various formats, including as electronically imaged documents. Confidentiality must be maintained and assured in all formats. Unless otherwise expressly set forth in Sections One through Six, no other documents or information may be placed or maintained in the County volunteer file, MCFRS operating record, or medical file.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

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