Research Governance and good clinical practice

This section contains the following:


Research governance is a mechanism for ensuring that all research on human subjects complies with all relevant legal and professional standards.  It broadly follows the internationally agreed arrangements set out in ICH Harmonised Tripartite Guideline Guideline For Good Clinical Practice for trials.  Clinical trials need to comply with Good Clinical Practice (GCP) guidelines and current data protection laws.  The regulatory framework may differ from country to country and investigators must ensure compliance with the appropriate regulations and regulatory bodies.

The 5 key areas of research governance are:

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Things to consider when writing a protocol

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Additional resources

Web resource iconICH Harmonised Tripartite Guideline Guideline For Good Clinical Practice

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

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Trial Protocol Tool resource iconChecklist for implications of Data Protection
This checklist has been contributed by Barbara Farrell who prepared it for the second version of the Trial Management Guide

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Web resource iconMRC Guidelines for Good Clinical Practice in Clinical Trials

This document provides guidelines for good clinical practice in trials.

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Web resource iconThe Data Protection Commission (UK)

This site provides information on Data Protection & Freedom of Information.

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Further reading

Pocock SJ. Clinical Trials: A Practical Approach. John Wiley and Sons, Chichester, 1983.

Duley L and Farrell B.  Clinical Trials. London: BMJ Books, 2002.

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This page was last updated 25th March 2005.