Monitoring
The monitoring of research in the NHS is an essential process to
ensure that patient/participant safety is maintained throughout and
that there is accurate reporting of results at its conclusion.
Under the UK Policy Framework for Health and Social Care
Research and Good Clinical Practice (GCP) guidelines, UH
Bristol has a responsibility to:
(i) Monitor research conducted on its premises
(ii) Monitor research which it sponsors
If your study is identified for monitoring, you will be
contacted by a member of the monitoring team to arrange a visit.
Monitoring can be in the form of (but is not limited to):
- Self-monitoring
- Site file review
- Protocol compliance
- Review of data for first patient recruited
- Close out visit
- Consent process
If you would like to know more about our monitoring process and
what to expect at a visit, please refer to our monitoring
procedure SOP 014
Monitoring and Oversight of Research.
If your study is a Clinical Trial of an Investigational
Medicinal Product (CTIMP) or a device trial, it may also be
identified for inspection by the Medicines and Healthcare products Regulatory
Agency (MHRA). Further information on your responsibilities can
be found in our SOP 008
Investigator Oversight of Research.
