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 EMA

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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The 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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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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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

Published by EMA

PandemyClinical Trials

The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine, access to public places (including hospitals) is limited due to the risk of spreading infections, and healthcare professionals are being reallocated

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Points to consider on implications of Coronavirus disease  (COVID-19) on methodological aspects of ongoing clinical  trials

Published by EMA

Clinical TrialsPandemy

This document points to consider on implications of Coronavirus disease  (COVID-19) on methodological aspects of ongoing clinical  trials

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