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Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 relevant ethics committee

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Document information
Reference GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area GBR
Scope(s) HM
Document name The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision 01-May-2004
Status Current
Document type Legal act
Language(s) EN
Description The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 — Unit 1.5.3
Scope HM
Document part Article 2

relevant ethics committee

Language EN
Original entry by Florian Adragna
Contributors
Tags Ethics committee, Definition, Clinical trial
Comment Definition of relevant ethics committee in the context of a clinical trial

Content

[…] “relevant ethics committee”, in relation to a clinical trial, means— (a)in a case where an ethics committee has given a favourable opinion in relation to that trial and paragraph 13 of Schedule 2 applies, the ethics committee which is the relevant ethics committee for that trial by virtue of sub-paragraph (5) of that paragraph; (b)in a case where an ethics committee has given an unfavourable opinion in relation to that trial but a favourable opinion has been given by an appeal panel in accordance with paragraph 4(4) of Schedule 4, that committee, or (c)in any other case, the ethics committee which has given a favourable opinion in relation to that trial in accordance with regulation 15; [...]