Property:DocType
From GxPlex
Document type (Legal act, Regulation, Guideline, …).
E
Official recommendation +
F
Official recommendation +
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025 +
Official recommendation +
Official recommendation +
Official recommendation +
Official recommendation +
G
Official recommendation +
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447 +
Official recommendation +
Official recommendation +
Official recommendation +
Official recommendation +
Official recommendation +
U
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018 +
Official recommendation +
Official recommendation +
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998 +
Official recommendation +
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018 +
Official recommendation +
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009 +
Official recommendation +
Official recommendation +
Official recommendation +
