Clinical Trial Documents

Here you can find clinical trial guidelines and regulatory documents that you may find useful arranged by category.

REGULATORY GUIDELINES

The three following regulatory guidelines documents are now available in single PDF. Click here to obtain your copy.

Declaration of Helsinki

A statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects.  Developed by the World Medical Association in 1964.

ICH Harmonised Tripartite Guideline for Good Clinical Practice (ICH GCP)

An international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.

EU Guidance on Good Manufacturing Practice: Annex 13 Manufacture of Investigational Medicinal Products

Supporting document to the European Commission Directive 2003/94/EC that provides detailed guidance on GMP in relation to the manufacture of IMPs.

DIRECTIVES

Regulation (EU) No 536/2014 on Clinical Trials on Medicinal Products for Human Use (Repealing Directive 2001/20/EC)

A new European Regulation on clinical trials was adopted in late May 2014, and will apply from 2019. Its main objective is to make it easier to conduct trials in several Member States of the European Union.

Clinical Trials Directive – Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001

The EU Clinical Trials Directive requires clinical trials on medicinal products for human use to be conducted according to the principles of ICH GCP.

GMP Directive – European Commission Directive 2003/94/EC

This Directive lays down the principles and guidelines of GMP for human medicines (marketed products and investigational products).

GCP Directive – Commission Directive 2005/28/EC of 8 April 2005

Principles and detailed guidelines with regards to IMPs  are specified to verify compliance of clinical trials with the Clinical Trials Directive 2001/20/EC.

STATUTORY LAW

Statutory Instrument 2004/1031 – The Medicines for Human Use (Clinical Trials) Regulations 2004

These regulations transpose the requirements of the Clinical Trials Directive 2001/20/EC and relevant provisions of the European Commission Directive 2003/94/EC into UK law.  The regulations came into force on 01 May 2004.

Statutory Instrument 2006/1928 – The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

Amendment 1 to SI 2004/1031 – implements the GCP Directive 2005/28/EC.  Came into force on 29 Aug 2006.  Explanatory memorandum .

Statutory Instrument 2006/2984 – The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006

Amendment 2 to SI 2004/1031 – addresses issues surrounding consent in emergency situations in incapacitated adults.  Came into force 12 Dec 2006.  Explanatory memorandum .

Statutory Instruments 2008/941 – The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008

Amendment 3 to SI 1031/2004 –enable children to take part in emergency care trials when there is not time to seek consent,  amend provisions relating to ethics committees, gene therapy advisory committees.  The regulations came into force on 01 May 2008.  Explanatory memorandum .