CGSB 191 1-2013-CAN CGSB-2013 Surveillance de l掗thique de recherches comportant des essais cliniques biom閐icaux.pdf

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1、CAN/CGSB-191.1-2013Research ethics oversight of biomedical clinical trialsICS 03.120.01National Standard of CanadaCopyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-The CANADIAN GENERAL

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23、roduction or networking permitted without license from IHS-,-,-NATIONAL STANDARD OF CANADA CAN/CGSB-191.1-2013Research ethics oversight of biomedical clinical trialsNATIONAL STANDARD OF CANADA CAN/CGSB-3.14-2006Prepared by the Approved by the Canadian General Standards BoardPublished May 2013 by the

24、 Canadian General Standards Board Gatineau, Canada K1A 1G6 HER MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public Works and Government Services, the Minister responsible for the Canadian General Standards Board (2013). No part of this publication may be reproduced in any

25、form without the prior permission of the publisher.CETTE NORME NATIONALE DU CANADA EST DISPONIBLE EN VERSIONSFRANAISE ET ANGLAISE.Copyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/C

26、GSB-191.1-2013CANADIAN GENERAL STANDARDS BOARDCommittee on Research Ethics Boards Reviewing Biomedical Clinical Trials(Voting membership at date of approval)Chair (non-voting)Griener, G.1National Council on Ethics in Human ResearchGeneral Interest CategoryKelly, J.M.H. Centre for Indigenous Research

27、, Culture, Language and Education (CIRCLE)Kovacs Burns, K. Best Medicines CoalitionLeonard, P. Canadian Patient Safety InstituteSczelecki, L. Canadian Cancer SocietyThomas, K. Canadian AIDS SocietyProducer CategoryClark, E. McGill University Health CentreCollins-Mrakas, A. York University, Office of

28、 Research EthicsCorman, J. Institutional Review Board ServicesGodlovitch, G. Conjoint Health Research Ethics Board/University of CalgaryLaviolette, M.A. Ottawa Hospital Research InstituteManzo, J. Ontario Institute for Cancer ResearchNeuman, R. Canadian Association of Research Ethics BoardsOwen, M.

29、Canadian Association of University Research AdministratorsPaige, C. University Health NetworkRolleston, F. Canadian Blood ServicesSaryeddine, T. Association of Canadian Academic Healthcare OrganizationsShort, D. Research Ethics Board Legal SocietySugarman, R. Hospital for Sick ChildrenVan Nie, A. Mc

30、Master University Faculty of Health SciencesRegulator CategoryKasina, A. Health Canada, InspectionsMonette, P. Health Canada, Science Policy DirectorateViner, N. Health Canada, Biologics the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.Copy

31、right Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/CGSB-191.1-20131CGSB 2013 All rights reservedResearch ethics oversight of biomedical clinical trials1 Scope This National Standard of C

32、anada applies to Research Ethics Boards (REBs) that evaluate applications for ethical acceptability. If an REB grants ethics approval to conduct biomedical clinical trials, it will provide research ethics oversight of biomedical clinical trials that are subject to the Food and Drugs Act and applicab

33、le Regulations (see 2.1). This Standard does not preclude or override any applicable regulatory or legal requirement.Intended users This Standard is intended for use primarily by REB chairs, members and administrative staff, qualified investigators and study teams conducting biomedical clinical tria

34、ls, sponsors and funders of biomedical clinical trials, those with responsibility for establishing and ensuring effective REB operations, those with responsibility for research ethics oversight of biomedical clinical trials in organizations where they are conducted, and regulatory authorities that e

35、valuate REBs with research ethics oversight of biomedical clinical trials.An organization with an REB intending to use this Standard will take responsible measures to ensure that the roles and responsibilities of the REB are defined, resources are made available, and processes are in place for resea

36、rch ethics oversight of biomedical clinical trials conducted under its auspices, to ensure that the REB meets the requirements of this Standard and applicable statutory and regulatory requirements.2 Normative references The following documents contain provisions that, through reference in this text,

37、 constitute provisions of this National Standard of Canada. The referenced documents may be obtained from the sources noted below.An undated reference is to the latest edition or revision of the reference or document in question, unless otherwise specified by the authority applying this standard. A

38、dated reference is to the specified revision or edition of the reference or document in question. However, parties to agreements based on this National Standard of Canada are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below.2.1

39、 Health CanadaFood and Drugs ActFood and Drug Regulations: Part C, Division 5, Drugs for Clinical Trials Involving Human SubjectsMedical Devices RegulationsNatural Health Products Regulations.Copyright Canadian General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduct

40、ion or networking permitted without license from IHS-,-,-2CAN/CGSB-191.1-2013CGSB 2013 All rights reserved2.1.1 SourceThe above may be obtained from the Department of Justice Canada, Communications Branch, Public Affairs Division, 284 Wellington Street, Ottawa, ON K1A 0H8, Telephone 613-957-4222, Fa

41、csimile 613-954-0811, http:/canada.justice.gc.ca.2.2 International Conference on Harmonisation (ICH)ICH GCP International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Guideline for Good Clinical Practice E

42、6(R1), http:/www.ich.org/LOB/media/MEDIA482.pdf.2.2.1 SourceThe above may be obtained from ICH Secretariat, c/o IFPMA, 15 ch. Louis-Dunant, P.O. Box 195, 1211 Geneva 20, Switzerland, Telephone +41 (22) 338 32 06, Facsimile: +41 (22) 338 32 30, http:/www.ich.org.2.3 World Medical AssociationWorld Med

43、ical Association, Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, http:/ SourceThe above may be obtained from the World Medical Association (WMA), 13, ch. du Levant, CIB - Btiment A, 01210 Ferney-Voltaire, France, Telephone +33 4 50 40 75 75, Facsimile: +3

44、3 4 50 40 59 37, http:/.3 Terms and definitions For the purposes of this National Standard of Canada, the following terms and definitions, and those set out in the Food and Drugs Act and applicable Regulations, apply:3.1applicantindividual, sponsor, institution or organization which applies to an RE

45、B for an ethics review of a biomedical clinical trial.3.2applicationrequest by an applicant for the initial review by an REB of a biomedical clinical trial or requests for review of protocol amendments, changes to consent documents, advertising, or any other materials or changes related to a clinica

46、l trial reviewed by the REB of Record as part of its research ethics oversight of the biomedical clinical trial.3.3assentaffirmative agreement to participate in a biomedical clinical trial given by a child or other person incapable of giving informed consent.3.4biomedical clinical trialinvestigation

47、 in which a health product (drug, medical device, or natural health product) is administered to or used by humans and that is intended to discover or verify the clinical, pharmacodynamic or pharmacokinetic effects of the product, or ascertain the safety or efficacy of the product.Copyright Canadian

48、General Standards Board Provided by IHS under license with CGSBNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-CAN/CGSB-191.1-20133CGSB 2013 All rights reserved3.5community membermember of the general public with no formal affiliation with the sponsor of the biomedical clinical trial, with the organization under whose auspices the biomedical clinical trial is being conducted, or with any site where the biomedical clinical trial is being conducted.NOTE An example of a community member is a patient or a former research subject.3.6conflict of interest