This document is the guideline of E6 on good clinical practice of The International Council for Harmonisation (ICH)
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INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE
E6(R2)
Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Internatonal Council for Harmonisation (ICH)Regulatory AuthoritiesThe International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.
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Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)
Published by EC
Clinical Trialinvestigational medicinal productsMedicinal ProductsEU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials
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Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC Text with EEA relevance
Published by EC
Clinical TrialsMedicinal Products
Recommendation paper on decentralised elements in clinical trials
Published by EMA
Decentralised Clinical TrialsRecommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected
View this resource Bookmark this resourceComputerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI)
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Clinical Trials Information System (CTIS) – Sponsor
Handbook
Published by EMA
Clinical Trials Information SystemCTISHandbookThis document is a compilation of key guidance, technical information, recommendations and
references for getting ready for use of CTIS
Guideline for the Notification of Serious Breaches of
Regulation (EU) No 536/2014 or the Clinical Trial Protocol
Published by EMA
assessmentclinical trial participantsClinical TrialscomplianceprotocolRegulation (EU) No 536/2014Serious Breachesservice providerSponsorsThis document describes the guideline for the notification of serious breaches of
Regulation (EU) No 536/2014
This guidance was developed in cooperation with the Roadmap Initiative to Good Lay
Summary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group of
the European Commission representing Ethics Committees and National Competent
Authorities (NCA)).
