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This page provides a simple browsing interface for finding entities described by a property and a named value. Other available search interfaces include the page property search, and the ask query builder.

List of results

• Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble  + (HM)
• Document:FRA AEC DOC010 V.04 01-Jun-2018  + (HM)
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  + (HM)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (HM)
• Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020  + (HM)
• Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015  + (HM)
• Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (HM)
• Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004  + (HM)
• Document:USA 21 CFR Part 312 09-Apr-2025  + (HM)
• Document:USA 21 CFR Part 314 09-Apr-2025  + (HM)
• Document:USA 21 CFR Part 320 09-Apr-2025  + (HM)
• Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998  + (HM)
• Document:ICH ICH E6 Guideline R3 (2025)  + (HM)
• Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2  + (HM)
• Document:ICH ICH E8 Guideline R1 (2021)  + (HM)
• Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019  + (HM)
• Document:ICH ICH E9 Guideline 1998  + (HM)
• Document:ICH ICH Guidelines -  + (HM)
• Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995  + (HM)
• Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005  + (HM)
• Document:WHO WHO - ICD 11  + (HM)
• Document:WHO World Health Organization -  + (HM)
• Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026  + (HM)
• Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0  + (HM)
• Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025  + (HM)

• Document:DEU AMG - Arzneimittelgesetz 19-Jul-2023  + (HM ; NIS ; Other)

• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (INS)
• Document:INT ISPE - GPP Revision 3 (2015)  + (INS)
• Document:N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008  + (INS)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 Preamble  + (IVD)
• Document:EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023  + (IVD)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (IVD)
• Document:AUT MPG – Medizinproduktegesetz 26-May-2022  + (MD)
• Document:DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021  + (MD)
• Document:DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021  + (MD)
• Document:EU MDCG Guidelines -  + (MD)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 Preamble  + (MD)
• Document:EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023  + (MD)
• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (MD)
• Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025  + (MD)
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  + (MD)
• Document:FRA SI RIPH 2G - Website 16-May-2025  + (MD)
• Document:GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021  + (MD)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (MD)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (MD)
• Document:GBR MEDDEV 2.7/3 revision 3 May-2015  + (MD)
• Document:GBR The Medical Devices Regulations 2002 11-Feb-2021  + (MD)
• Document:USA 21 CFR Part 812 09-Apr-2025  + (MD)
• Document: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  + (MD)
• Document:IMDRF IMDRF – Guidelines -  + (MD)
• Document:ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020  + (MD)