Clinical Trials

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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)

Regulatory AuthoritiesInternatonal Council for Harmonisation (ICH)

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

Clinical TrialsGood Clinical Practice (GCP)

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 on the management of clinical trials during the COVID-19 (Coronavirus) 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

PediatricClinical Trials

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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