Obligations Regarding IRB Review/Decisions Sample Clauses

Obligations Regarding IRB Review/Decisions. 1. FWA; Central IRB Review in Accordance with FWA. ABC will maintain a current, approved FWA with OHRP for the duration of this Agreement. ABC will notify the Central IRB (via the NCRI CCC) promptly in writing if its FWA is threatened, terminated, or expires for any reason. The Central IRB will perform initial review and continuing oversight of the Clinical Studies included in this Agreement in accordance with the human subjects protection requirements of ABC’s OHRP- approved FWA and the federal regulations and ethical principles referenced therein. Review by the Central IRB will take into account the requirements of the local research context identified by ABC pursuant to the Reliance SOP and Sections II.2(b) and III.4 of this Agreement. ABC shall provide a copy of its FWA to the Central IRB (via the NCRI CCC) with the NEALS Member IRB Information Sheet and thereafter upon any material change or renewal. Material change includes, but is not limited to, a change in the components of ABC that are covered under the FWA.
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Obligations Regarding IRB Review/Decisions. 1. FWA; Central IRB Review in Accordance with FWA. ABC will maintain a current, approved FWA with OHRP for the duration of this Agreement. ABC will notify the Central IRB (via the NeuroNEXT CCC) promptly in writing if its FWA is threatened, terminated, or expires for any reason. The Central IRB will perform initial review and continuing oversight of the Clinical Studies included in this Agreement in accordance with the human subjects protection requirements of ABC’s OHRP- approved FWA and the federal regulations and ethical principles referenced therein. Review by the Central IRB will take into account the requirements of the local research context identified by ABC pursuant to the Reliance SOP and Sections II.2(b) and III.4 of this Agreement. ABC shall provide a copy of its FWA to the Central IRB (via the NeuroNEXT CCC) with the NeuroNEXT Clinical Study Site IRB Information Sheet and thereafter upon any material change or renewal. Material change includes, but is not limited to, a change in the components of ABC that are covered under the FWA.
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Related to Obligations Regarding IRB Review/Decisions

  • ADB’s Review of Procurement Decisions 9. All contracts procured under international competitive bidding procedures and contracts for consulting services shall be subject to prior review by ADB, unless otherwise agreed between the Borrower and ADB and set forth in the Procurement Plan. SCHEDULE 5

  • Ongoing Review and Revisions As set forth in Section 35.7, the Parties have agreed to the coordination and exchange of data and information under this Agreement to enhance system reliability and efficient market operations as systems exist and are contemplated as of the Effective Date. The Parties expect that these systems and the technology applicable to these systems and to the collection and exchange of data will change from time to time throughout the term of this Agreement. The Parties agree that the objectives of this Agreement can be fulfilled efficiently and economically only if the Parties, from time to time, review and, as appropriate, revise the requirements stated herein in response to such changes, including deleting, adding, or revising requirements and protocols. Each Party will negotiate in good faith in response to such revisions the other Party may propose from time to time. Nothing in this Agreement, however, shall require any Party to reach agreement with respect to any such changes, or to purchase, install, or otherwise implement new equipment, software, or devices, or functions, except as required to perform this Agreement.

  • Review by the Bank of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the Bank’s Prior Review. All other contracts shall be subject to Post Review by the Bank.

  • CONTRACTOR’S SUBMISSION OF CONTRACT MODIFICATIONS In connection with any Contract modification, OGS reserves the right to:  request additional information  reject Contract modifications  remove Products from Contract modification requests  request additional discounts for new or existing Products

  • REVIEW OF CONTRACT DOCUMENTS 4.2.1 The Contractor shall carefully study and compare the Contract Documents and shall immediately report in writing to the Architect and the State any error, inconsistency or omission he may discover. The Contractor shall not be liable to the State or the Architect for any damage resulting from any such errors, inconsistencies or omissions in the Contract Documents. The Contractor shall perform no portion of the Work at any time without Contract Documents or, where required, approved Shop Drawings, Product Data or Samples for such portion of the Work.

  • Review by the World Bank of Procurement Decisions The Procurement Plan shall set forth those contracts which shall be subject to the World Bank’s Prior Review. All other contracts shall be subject to Post Review by the World Bank.

  • Agreement Review If, pursuant to section 25.10 (Review of Agreement) of the Bilateral Agreement, the Bilateral Agreement is reviewed after three or five years, or both, of the effective date of the Bilateral Agreement, and any changes to the Bilateral Agreement are required as a result, the Parties agree to amend the Agreement as necessary and in a manner that is consistent with such changes.

  • Project Review A. Programmatic Allowances

  • Additional RO Review Criteria (1) In addition to the requirements in Subparagraph 34A, the RO must:

  • ADDITIONAL CONTRACTOR RESPONSIBILITIES 13 In addition to providing the services described in Paragraph 5 of this 14 Exhibit A, CONTRACTOR agrees to:

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