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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 Kingdo Brexit Withdrawal Agreement Qualified Person

This 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 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Clinical Trials Statistical 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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Assent or Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

Published by EMA

Informed Guidance Assent Guidance Paediatric Clinical Trials

This document is the guidance about Assent or Informed Consent for Paediatric Clinical Trials with Medicinal Products in
Europe

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CIOMS Cumulative Pharmacovigilance GLOSSARY. Version 1.1

Published by CIOMS

CIOMS Pharmacovigilance

This document makes a list of Glossary about Cumulative Pharmacovigilance of : Council for International
Organizations of Medical Sciences (CIOMS)

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Clinical Trials Information System (CTIS) – Sponsor Handbook

Published by EMA

Handbook CTIS Clinical Trials Information System

This document is a compilation of key guidance, technical information, recommendations and
references for getting ready for use of CTIS

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Good Lay Summary Practice

Published by European Commission (EC)

Clinical Trials Good Practice

This guidance was developed in cooperation with the Roadmap Initiative to Good Lay
Summary Practice and adopted by the Clinical Trials Expert Group (CTEG, a working group of
the European Commission representing Ethics Committees and National Competent
Authorities (NCA)).

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Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol

Published by EMA

Clinical Trial Protocol Regulation 536/2014 Serious Breaches Guideline

This document describes the guideline for the notification of serious breaches of
Regulation (EU) No 536/2014

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Clinical trials – Regulation EU No 536/2014

Published by European Commission (EC)

Regulation Clinical Trials Good Clinical Practice (GCP)Good Manufacturing Practice

The inspection of clinical trials may concern good clinical practice as regards the conduct of clinical trials as well as good manufacturing practices as regards the manufacturing of the investigational medicinal products.

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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 Trials Good 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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Technical Notice to Sponsors Regarding Continuous Compliance With The EU Legislation For Clinical Trials Following The Withdrawal Of The United Kingdom From The EU

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

Assent or Informed Consent Guidance for Paediatric Clinical Trials with Medicinal Products in Europe

CIOMS Cumulative Pharmacovigilance GLOSSARY. Version 1.1

Clinical Trials Information System (CTIS) – Sponsor Handbook

Good Lay Summary Practice

Guideline for the Notification of Serious Breaches of Regulation (EU) No 536/2014 or the Clinical Trial Protocol

Clinical trials – Regulation EU No 536/2014

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

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