Research Governance and good clinical practice
This section contains the following:
Introduction
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:
- Ethics. Gaining informed consent, protecting patient
confidentiality, involving participants in designing the research
- Science. Preventing duplication, ensuring research is well
designed, regulating medicines in research
- Information. Ensuring that research findings are published and
accessible
- Health & safety. Ensuring the safety of staff and participants
- Finance. Being accountable for spending public funding on research
Back to top
Things to consider when writing a
protocol
- Include description of procedures to ensure compliance with Good
Clinical Practice or other relevant guidelines on clinical research.
Back to top
Additional resources
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.
Back to top
This checklist has been contributed by Barbara Farrell who prepared it
for the second version of the Trial Management Guide
Back to top
This document provides guidelines for good clinical practice in
trials.
Back to top
This site provides information on Data Protection & Freedom of
Information.
Back to top
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.
Back to top
This page was last updated 25th March 2005.
ICH Harmonised Tripartite
Guideline Guideline For Good Clinical Practice
Checklist for implications
of Data Protection