Title... part... CFR раздел 21 части 56 Свода федеральных нормативных актов США (CFR)

Creator:	Elena Doroshenko
Language pair:	English to Russian
Discipline:	-
Definition / notes:	Ethics Committee This study will be conducted in compliance with Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines - including Title 21 Part 56 of the US Code of Federal Regulations (CFR) relating to IRBs/IECs and GCP as described in the US Food and Drug Administration (FDA) CFR (21 CFR § 50, 56, 312) - in accordance with applicable ICH regulations regarding clinical safety data management (E2A, E2B[R3]), European Community directives 2001/20, 2001/83, 2003/94 and 2005/28 as enacted into local law, and with ICH guidelines regarding scientific integrity (E4, E8, E9, and E10). раздел 21 части 56 Свода федеральных нормативных актов США (CFR)
URL:	http://http://www.proz.com/kudoz/english_to_russian/medical_pharmaceuticals/6247297-title_21.html