Clinical Trials

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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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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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Preparedness of medicines’ clinical trials in paediatrics

Published by EMA

Clinical TrialsPediatric

This document was developed by a working group of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) 1 and sets out recommendations for discussions about clinical trial preparedness in paediatrics.

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Clinical Trials Facilitation and Coordination Group Guidance document for sponsors for a Voluntary Har

Published by EMA

Clinical Trials

The main objectives of the assessment of the CT are to ensure the quality of the IMP and the safety of the trial subjects.

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