It is a good practice requirement that all research is registered in a public research register before it starts. The UK Policy Framework for Health and Social Care Research says:
In order to avoid waste, information about research projects (other than those for educational purposes) is made publicly available before they start (unless a deferral is agreed by or on behalf of the Research Ethics Committee).
For drug trials (clinical trials of investigational medicinal products) other than adult phase I trials, this is also a legal requirement.
For drug trials and all other types of clinical trial, not registering within six weeks of recruiting the first patient is a breach of approval conditions, unless a deferral has been agreed by or on behalf of the Research Ethics Committee.
See research registration and research project identifiers for further details.
We publish details of all research reviewed by REC in the UK in the research summaries section of our website. This includes information about the planned research, a summary of the research as submitted to the REC and the REC’s opinion.
We also publish details of all applications approved by the Confidentiality Advisory Group (CAG) in the CAG registry. This contains summary information about the activity, details of the identifiers approved and applicant contact details.
Clinical trial registration audits
We undertake annual audits to determine the number of clinical trials over a specified time that meet the condition of the favourable opinion to register on a publicly accessible database.
Reports of our audits are available below:
- Clinical trial registration audit report: 1 January 2015 to 30 June 2015 (part 1)
- Clinical trial registration audit report: 1 January 2015 to 30 June 2015 (part 2)
- Clinical trial registration audit report: 1 January 2016 to 30 June 2016
- Clinical trial registration audit report: 1 January 2017 to 30 June 2017