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;