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 TrialMedicinal Productsinvestigational medicinal products

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

View this resource Bookmark this resource

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

View this resource Bookmark this resource

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)

View this resource Bookmark this resource

CAMPUS

Published by ECRIN

Clinical Trials Toolkit

A search tool for regulatory requirements on clinical trials per country. Launched in December 2015 by the European Clinical Research Infrastructure Network (ECRIN) – this is an online database including country-specific information on regulatory and ethical requirements in clinical research across Europe

View this resource Bookmark this resource

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.

View this resource Bookmark this resource

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.

View this resource Bookmark this resource