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All SubjectsClinical Trials

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

Published by EMA

Clinical TrialsPandemy

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

PandemyClinical Trials

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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ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials to the Guideline on Statistical Principles for Clinical Trials Step 5 

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

Clinical TrialsStatistical Principles

This document is an addendum on estimands and sensitivity
analysis in clinical trials to the guideline on statistical
principles for clinical trials 

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Council for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Health-related Research Involving Humans. 2016. 

Published by Council for International Organizations of Medical Sciences (CIOMS) 

Clinical TrialsObservational ResearchBiobankingEpidemiological Studies

The Working Group decided to broaden the scope of the 2002 Guidelines from “biomedical research”
to “health-related research”. The Working Group considered biomedical research too narrow since that
term would not cover research with health-related data.

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DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001

Published by Official Journal of the European Communities

Clinical TrialsGood Clinical Practice (GCP)

This Directive establishes specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice. This Directive does not apply to non-interventional trials.

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