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Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council Text with EEA relevance
(Including NIS) +
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Common Terminology Criteria for Adverse Events (CTCAE)
Version 5.0
Published: November 27, 2017
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES +
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Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ( ‘CT-3’ ) +
Complex clinical trials – Questions and answers
Version 2022-05-23 +
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USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020 +
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
Guidance for Industry, Investigators, and Institutional Review Boards +
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Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine +
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CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 +
Council for International Organizations of Medical Sciences (CIOMS)
International Ethical Guidelines for Biomedical Research Involving Human Subjects +
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DEVELOPMENT SAFETY UPDATE REPORT +
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DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 4 April 2001
on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
The European Directive (2001/20/EC) no longer applies in the UK. The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU. +
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL - of 27 October 1998
on in vitro diagnostic medical devices +
Data Protection Act 2018
2018 CHAPTER 12
An Act to make provision for the regulation of the processing of information relating to individuals; to make provision in connection with the Information Commissioner's functions under certain regulations relating to information; to make provision for a direct marketing code of practice; and for connected purposes. +
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Declaration of Helsinki
Medical Research Involving Human Participants
The Declaration of Helsinki (DoH) is the World Medical Association’s (WMA) best-known policy statement. The first version was adopted in 1964 and has been amended seven times since, most recently at the General Assembly in October 2024. The current (2024) version is the only official one; all previous versions* have been replaced and should not be used or cited except for historical purposes. The WMA would like to thank all those who submitted comments and suggestions for the most recent revision of the DoH. +
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Deutsches Ärzteblatt
Publication of the GCP related courses programms in Germany for trial site personnel, by the German federal chamber of physicians. +
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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use +
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Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual
The Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials (SCORE) Manual describes operational requirements for Clinical Research Sites (CRSs) implementing DAIDS-sponsored clinical research within the DAIDS Clinical Trials Networks. This manual serves as a resource for CRSs by consolidating operational requirements in a central location and providing tools to facilitate compliance with these requirements. CRS staff should direct any questions related to these requirements to their Office of Clinical Site Oversight (OCSO) Program Officers (POs) and/or the Pharmaceutical Affairs Branch (PAB) Pharmacists as appropriate. +
Division of AIDS (DAIDS) Site Clinical Operations and Research Essentials
(SCORE) Manual Appendix: Source Documentation Requirements +
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E21: Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
Dated 26 May 2023 +
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EMA – Medical Device Coordination Group (MDCG)
Guidance - MDCG endorsed documents and other guidance:
- Annex XVI products (Regulation EU 2017/745)
- Borderline and Classification
- Class I Devices
- Clinical investigation and evaluation
- COVID-19
- Custom-Made Devices
- European database on medical devices (EUDAMED)
- European Medical Device Nomenclature (EMDN)
- Implant cards
- In-house devices
- Authorised Representatives, Importers, Distributors
- In Vitro Diagnostic medical devices (IVD)
- New technologies
- Notified bodies
- Person responsible for regulatory compliance (PRRC)
- Post-Market Surveillance and Vigilance (PMSV)
- Standards
- Unique Device Identifier (UDI)
- Other topics
- Other guidance documents +
EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838 +
EMA/216030/2025
EMA staff members who have a Copilot 365 license can utilise Copilot's AI features in different context to support their day-to-day activities based on a risk-based methodology. +
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 +
EMA/431265/2016
Annex I – to guidance for the conduct of good clinical practice inspections – investigator site +
