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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:GBR Data Protection Act 2018 06-Jun-2022  + (Legal act)
• Document:GBR Directive 2001/20/EC 04-Apr-2001  + (Legal act)
• Document:GBR Directive 90/385/EEC 05-Sep-2007  + (Legal act)
• Document:GBR Directive 93/42/EEC 11-Oct-2007  + (Legal act)
• Document:GBR Directive 98/79/EC 20-Dec-2011  + (Legal act)
• Document:GBR Medicines and Medical Devices Act 2021 21-Feb-2021  + (Legal act)
• Document:GBR National Health Service Act 2006 02-Dec-2019  + (Legal act)
• Document:GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019  + (Legal act)
• Document:GBR The Human Medicines Regulations 2012 01-Jan-2025  + (Legal act)
• Document:GBR The Medical Devices Regulations 2002 11-Feb-2021  + (Legal act)
• Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004  + (Legal act)
• Document:GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020  + (Legal act)
• Document:USA 21 CFR Part 11 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 312 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 314 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 320 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 50 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 54 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 56 09-Apr-2025  + (Legal act)
• Document:USA 21 CFR Part 809 06-May-2024  + (Legal act)
• Document:USA 21 CFR Part 812 09-Apr-2025  + (Legal act)
• Document:USA 42 CFR Part 11 09-Apr-2025  + (Legal act)
• Document:USA 45 CFR Part 160 09-Apr-2025  + (Legal act)
• Document:USA 45 CFR Part 46 09-Apr-2025  + (Legal act)
• Document:USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023  + (Legal act)
• Document:USA U.S. Code Title 21 30-Sep-2023  + (Legal act)

• Document:N.A. Article from Mora et al. 2023  + (Litterature article)
• Document:N.A. SPIRIT 2013 - Chan et al. 2013  + (Litterature article)

• Document:EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017  + (Official guideline)
• Document:EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021  + (Official guideline)
• Document:EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022  + (Official guideline)
• Document:EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023  + (Official guideline)
• Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023  + (Official guideline)
• Document:EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022  + (Official guideline)
• Document:EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018  + (Official guideline)
• Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005  + (Official guideline)
• Document:EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)  + (Official guideline)
• Document:EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)  + (Official guideline)
• Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020  + (Official guideline)
• Document:GBR MEDDEV 2.7/3 revision 3 May-2015  + (Official guideline)
• Document:DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021  + (Official recommendation)
• Document:DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018  + (Official recommendation)
• Document:DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022  + (Official recommendation)
• Document:EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)  + (Official recommendation)
• Document:EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022  + (Official recommendation)
• Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017  + (Official recommendation)
• Document:EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020  + (Official recommendation)
• Document:FRA AEC DOC010 V.04 01-Jun-2018  + (Official recommendation)
• Document:FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025  + (Official recommendation)
• Document:FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025  + (Official recommendation)
• Document:FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024  + (Official recommendation)
• Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025  + (Official recommendation)