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List of results
- Document:AUT AMG – Arzneimittelgesetz 04-Mar-2023 +
- Document:DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 +
- Document:EU CHMP Guidelines - +
- Document:EU EMA Guidelines - +
- Document:EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 +
- Document:EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005 +
- Document:EU EudraLex – Volume 10 - +
- Document:EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017 +
- Document:EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 +
- Document:EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 Preamble +
- Document:FRA AEC DOC010 V.04 01-Jun-2018 +
- Document:FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025 +
- Document:GBR Directive 2001/20/EC 04-Apr-2001 +
- Document:GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020 +
- Document:GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015 +
- Document:GBR The Human Medicines Regulations 2012 01-Jan-2025 +
- Document:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 +
- Document:USA 21 CFR Part 312 09-Apr-2025 +
- Document:USA 21 CFR Part 314 09-Apr-2025 +
- Document:USA 21 CFR Part 320 09-Apr-2025 +
- Document:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 +
- Document:ICH ICH E6 Guideline R3 (2025) +
- Document:ICH ICH E6 Guideline - Annex 2 R3 Annex 2 +
- Document:ICH ICH E8 Guideline R1 (2021) +
- Document:ICH ICH E9 Guideline - Addendum R1 20-Nov-2019 +
- Document:ICH ICH E9 Guideline 1998 +
- Document:ICH ICH Guidelines - +
- Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 +
- Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 +
- Document:WHO WHO - ICD 11 +
- Document:WHO World Health Organization - +
- Document:WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026 +
- Document:N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0 +
- Document:N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025 +
