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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ECRIN – European Clinical Research Infrastructure Network. Fast track procedure for COVID19 trials
Published by ECRIN
PandemyClinical TrialsECRIN – European Clinical Research Infrastructure Network. Fast track procedure for COVID19 trials
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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
Published by EMA
Clinical TrialsPandemyThe 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 TrialsPandemyThis document points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
View this resource Bookmark this resourceThis 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 TrialsThe 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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Clinical Trials Regulation (EU) NO 536/2014 Questions and Answers
Published by European Commission
Clinical TrialsQuestions and AnswersThis document makes a list of questions and answers related to new EU Regulation 536/2014 on conducting clinical trials
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Technical Notice to Sponsors Regarding Continuous Compliance With The EU Legislation For Clinical Trials Following The Withdrawal Of The United Kingdom From The EU
Published by European Commission, EMA) and Head of Medicines Agencies (HMA)
United KingdoBrexitWithdrawal AgreementQualified PersonThis document describes the technical notice related to Brexit and the clinical trials ongoing in the EU whose the Qualified Person resides in the UK
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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 EMA
Clinical TrialsStatistical PrinciplesThis document is an addendum on estimands and sensitivity
analysis in clinical trials to the guideline on statistical
principles for clinical trials
Assent or Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in
Europe
Published by EMA
Assent GuidanceInformed GuidancePaediatric Clinical TrialsThis document is the guidance about Assent or Informed Consent for Paediatric Clinical Trials with Medicinal Products in
Europe