Independent Ethics Committee (IEC) definition

Independent Ethics Committee (IEC) means an independent body (a review board or a committee, institutional, regional, national or supranational), consisting of medical/scientific professionals and non-medical/non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the Protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting the informed consent of Study Patients.
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Examples of Independent Ethics Committee (IEC) in a sentence

  • The Independent Ethics Committee (IEC) will also be informed promptly and provided with the reason(s) for the termination or suspension by the Sponsor or by the Clinical Investigator/investigation sites.

  • Authorized representatives of Sage Therapeutics, a regulatory authority, an Independent Ethics Committee (IEC) or an IRB may visit the site to perform audits or inspections, including source data verification.

  • The parties acknowledge that Protocol Amendments are also subject to approval by the responsible Independent Ethics Committee ("IEC").

  • The study will receive approval from an Independent Ethics Committee (IEC) prior to commencement and where applicable by law also from National Competent Authorities.

  • Documents The investigator and the study site must accept auditing by the sponsor as well as inspections from the Independent Ethics Committee (IEC) and relevant regulatory authorities.

  • RIBOMIC (or designee) will provide the Principal Investigator with a reporting cover letter and an anonymized MedWatch 3500A for expedited reporting of SAEs to the IRB or Independent Ethics Committee (IEC).

  • The Sponsor will comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, Institutional Review Board (IRB) or Independent Ethics Committee (IEC), and Investigators.

  • BioNTech as the sponsor and Regulatory Approval holder of the Clinical Trials shall ensure that the Clinical Trial is approved by and subject to continuing oversight by an appropriate Institutional Review Board (IRB) or Independent Ethics Committee (IEC), except that BioNTech shall delegate this responsibility to Pfizer for any Clinical Trial for which Pfizer is the Lead Development Party.

Related to Independent Ethics Committee (IEC)

  • Ethics Committee means an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients' organisations;

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

  • OPSI Advisory Committee means the committee established under Tariff, Attachment M, section III.G.

  • standards committee (“pwyllgor safonau”) means the standards committee of the county or county borough council which has functions in relation to the community council for which it is responsible under section 56(1) and (2) of the Local Government Act 2000.

  • Transition Committee shall have the meaning set forth in Section 2.14.

  • Compliance Committee means the committee referenced under the Federated Code of Business Conduct and Ethics, consisting of, among others, the Chief Compliance Officer, the General Counsel, the Chief Audit Executive and the Chief Risk Officer.

  • Independent Board Committee means the independent board committee of the Company

  • Audit Committee means the audit committee of the board of directors of the Company established pursuant to the Articles, or any successor committee.

  • 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.

  • 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.

  • Technical Committee means the body established in accordance with article VII;

  • Evaluation Committee means a body appointed to perform the evaluation of Offerors’ proposals.

  • Peer review committee means one or more persons acting in a peer review capacity who also serve as an officer, director, trustee, agent, or member of any of the following:

  • Evaluation Committee Report means a report prepared by the Procurement Manager and the Evaluation Committee for contract award. It will contain written determinations resulting from the procurement.

  • Appeal Committee means the appeal committee established by the Council in terms of section 12(3)(a);

  • Audit Committee Financial Expert means a person who has the following attributes:

  • Board of Review or “board” means the state building code board of review created by Iowa Code section 103A.15. The three members of the board of review are appointed by the building code commissioner from among the membership of the building code advisory council.

  • Nominating Committee means the nominating committee of the board of directors of the Company established pursuant to the Articles, or any successor committee.

  • Supervisory Committee means the Comisión Fiscalizadora of the Company.

  • Regional Committee means the regional committee on school

  • Review Committee or “Committee” means a committee established pursuant to rule Chapter 67-60, F.A.C.

  • Advisory Committee means the Employer's Advisory Committee as from time to time constituted.

  • Nomination Committee means the nomination committee of the Board established in accordance with Article 116;

  • Benefits Committee means the Employee Benefits Committee of Textron.

  • Independent Board Member means a trustee of the Fund who is neither an “interested person” of the Fund as defined in Section 2(a)(19) of the Investment Company Act of 1940, as amended, nor a party to the Proceeding with respect to which indemnification or advances are sought.

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