Investigational Review Board definition

Investigational Review Board or “IRB” means in accordance with 45 C.F.R. 46, Protection of Human Subjects (Revised November 13, 2001) and 21 C.F.R. 45, Subpart C, IRB Functions and Operations, (as amended June 18, 1991 and other applicable regulations), an independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the subjects involved in a clinical trial. It may also be referred to as an IEC in accordance with ICH E6, Section 1.27.
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Examples of Investigational Review Board in a sentence

  • Dr. Geriak is a specialized Pharmacist and has a system-wide position on the Investigational Review Board for Sharp Healthcare, which owns 5 hospitals and various clinics throughout San Diego County.

  • The Institution's obligations to conduct the Study are expressly conditional upon the approval of its Investigational Review Board, which the parties and the Principal Investigator will cooperate to obtain.

  • As used herein, (i) the term “CRO” means any third-party contract research organization used to conduct the Combination Study, including laboratories and third parties used to maintain the safety database from the Combination Study, but, for clarity, excludes clinical trial sites and any third parties who are individuals; and (ii) the term “IRB” means an Investigational Review Board or Ethics Committee (or similar body in a given country).

Related to Investigational Review Board

  • Institutional Review Board or “IRB” means, in accordance with 45 C.F.R. Part 46, 21 C.F.R. part 56, and other applicable regulations, an independent body comprising medical, scientific, and nonscientific members, whose responsibility is to ensure the protection of the rights, safety, and well-being of the Human Subjects involved in a study.

  • Review Board has the meaning provided in Section 2.1(f)(i) of this Commercial Shared-Loss Agreement.

  • Architectural Review Committee or “ARC” shall mean the architectural review committee established by the Organization to review plans submitted to the Organization for architectural review.

  • Complaint Investigation means an investigation of any complaint that has been made to a proper authority that is not covered by an abuse investigation.

  • Expedited review means an examination, in accordance with

  • independent review committee means the independent review committee of the investment fund established under National Instrument 81-107 Independent Review Committee for Investment Funds;

  • Environmental Review means the Federal

  • Independent review organization means an entity that is accredited to conduct independent external reviews of adverse benefit determinations.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Review means a financial or operational audit, investigation, inspection or other form of review requested or required by the LHIN under the terms of LHSIA or this Agreement, but does not include the annual audit of the HSP’s financial statements;

  • Benchmark Review means a review of the Services carried out in accordance with paragraphs 2.1 to 2.3 of Schedule 7 (Value for Money) of this Framework Agreement to determine whether those Services represent Good Value;

  • Joint Remediation Committee has the meaning set forth in Section II.A.2.

  • External Review means an independent review of an Adverse Benefit Determination conducted by an Independent Review Organization.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • clinical investigation means any systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a device;

  • Evaluation Team means the team appointed by the City; “Information Meeting” has the meaning set out in section 2.2;