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.

  • All of our clinical research trials have full Investigational Review Board (IRB) approval and are conducted by experienced research personnel, assuring good clinical practice.

  • Please include the approval letter from the Investigational Review Board (IRB) or Animal Care and Use Committee (ACUC) or, if approval has not yet been received, a copy of the submitted application to IRB or ACUC.

  • The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, how much will be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions.

  • 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.

  • The Investigational Review Board (IRB), under proper submittal of required information and presentation of the protocol for review, approves or disapproves protocols as deemed clinically appropriate.

  • The Applicant stated that: • The protocol, protocol amendments, and informed consent documents were reviewed and approved by an Investigational Review Board (IRB) in accordance with the provisions of 21 CFR Part 56.• The study was carried out in accordance with Good Clinical Practice (GCP) and the United States (US) Code of Federal Regulations, Title 21.

  • A copy of the signed consent form will be given to each guardian.For any sites that choose to execute an IRB reliance agreement, Boston Children’s Hospital Investigational Review Board, as part of the reliance agreement, will provide each site with the informed consent template with prompted areas for each institution’s required language.

  • The IRB-approved protocol and supporting documents (consent forms, product-specific risk statements, and recruitment flyers in both English and Spanish) appears in Volume 2 of the AHETF submission.Documentation of all interactions between the investigators and the Independent Investigational Review Board, Inc., of Plantation FL appears in Volume 8 of the AHETF submission.

  • The study protocol, informed consent forms (all versions), and any specific advertising will be submitted to and approved by the Investigational Review Board (IRB) before the start of the study.

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.

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;

  • 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;

  • ATTORNEY REVIEW The Purchaser acknowledges that Purchaser has had the opportunity to consult with its legal counsel regarding this Agreement and that accordingly the terms of this Agreement are not to be construed against any party because that party drafted this Agreement or construed in favor of any Party because that Party failed to understand the legal effect of the provisions of this Agreement.

  • 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 Funder under the terms of the Enabling Legislation or this Agreement, but does not include the annual audit of the HSP’s financial statements;

  • Investigating Committee means any Officer/Committee appointed by Competent Authority to conduct investigation.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Supervisory Review means ongoing clinical case reviews in accordance with procedures developed by ADMINISTRATOR, to determine the appropriateness of Diagnosis and treatment and to monitor compliance to the minimum ADMINISTRATOR and Medi-Cal charting standards. Supervisory review is conducted by the program/clinic director or designee.

  • Medical Review Officer (MRO) means a licensed physician responsible for receiving and reviewing laboratory results generated by the school district’s drug testing program and for evaluating medical explanations for certain drug tests.

  • 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;

  • District Evaluation Advisory Committee means a group created to oversee and guide the planning and implementation of the Board of Education's evaluation policies and procedures as set forth in N.J.A.C. 6A:10-2.3.

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • Prospective review means utilization review conducted prior to an admission or a course of treatment.

  • investigating authority means an authority that in terms of national legislation may investigate unlawful activities;

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

  • Medical Review Officer (MRO means a licensed physician, employed with or contracted with the City, responsible for receiving laboratory results generated by the City's drug testing program who has knowledge of substance abuse disorders, laboratory testing procedures, and chain of custody collection procedures; who verifies positive, confirmed test results, and who has the necessary and appropriate medical training to interpret and evaluate an individual's confirmed positive test result together with his or her medical history and any other relevant biomedical information.