National Research Ethics Service

Clinical trials directive and its implementation in the UK

ADPH and FPH statement on funding of experimental treatments Statement on funding of experimental treatments
Care after researchThere are ethical and practical issues, in particular when participants may wish to continue on the study intervention after the study. There are also various guidelines and legislation. This document presents a framework of questions to help NHS RECs and their applicants. Information on this document’s development is here.
CG guidance on serious non-compliance with regulations CG guidance on serious non-compliance with regulations
Data Monitoring Committees in Clinical Trials Guidance for Research Ethics Committees
For guidance on applying for clinical trials authorisation (External link)
Guidance for EudraCT (External link)
Implementation of good clinical practice: conduct of clinical trials on medicinal products
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.
Informed consent in CTIMPs NRES information paper on informed consent in clinical trials of investigational medicinal products
Membership of Research Ethics Committees NRES information paper on membership of research ethics committees (RECs) version 4.1
Memorandum of Understanding (MoU) Memorandum of Understanding (MoU) between MHRA, NRES, GTAC and AAPEC on clinical trials of investigational medicinal products (CTIMPs)
MHRA guidance on reporting serious breaches of GCP or the protocol in CTIMPs MHRA guidance on Reporting serious breaches of GCP or the protocol in CTIMPs (external link)
MoU Summary between MHRA, COREC and GTAC on CTIMPs Summary of the MoU between MHRA, NRES, GTAC and AAPEC on CTIMPs.
NRES Letter: Treatment after clinical trials Continued treatment for research participants at the end of a clinical trial NRES letter dated 13 March 2008.
The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006
(External link) - Statutory Instrument 2006 No. 2984
The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
(External link) Statutory Instrument 2006 No. 1928
The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment)
(External link) Statutory Instruments 2008 No. 941
The Medicines for Human Use (Clinical Trials) Regulations 2004
(External link) - Statutory Instrument 2004 No. 1031