Clinical Trials

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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

Medicinal Productsinvestigational medicinal productsClinical Trial

EU Regulation setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials

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Recommendation paper on decentralised elements in clinical trials

Published by EMA

Decentralised Clinical Trials

Recommendations 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

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Guideline on computerised systems and electronic data in clinical trials

Published by EMA

Computerised 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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ECRIN CAMPUS for Regulatory and Ethical Requirements

Published by ECRIN

ECRIN CAMPUS is a central resource for information about clinical trial regulatory and ethical requirements covering 22 European countries and multiple study types such as clinical drug trials, clinical investigations of medical devices, combination drug-device studies and nutritional studies.

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ICH E6 (R2) Good clinical practice

Published by EMAInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Good Clinical Practice (GCP)Ethics Committee

This document addresses the good clinical practice, an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. It aims to provide a unified standard for the ICH regions to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

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Good clinical practice

Published by EMA

Good Clinical Practice (GCP)Clinical Trials

The scope of this Reflection Paper is to clarify the practical application of requirements for clinical trials conducted outside of the EU/EEA and submitted in Marketing Authorisation Applications to the EMA (through the centralised procedure) or to National competent Authorities (through decentralised, mutual recognition, or national procedures) . The Paper set up practical steps to be undertaken during the provision of guidance and advice in the medicine development phase and during the evaluation of Marketing Authorisation Applications.

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