Appendix II Retention schedule: Clinical trials and research
This appendix sets out the retention period for different types of clinical trials and research relating to health and care.
This appendix sets out the retention period for different types of clinical records relating to health and care. Where indicated, Appendix III should also be referred to. This sets out further detail relating to the management of specific types and formats of records.
Advanced medical therapy research: master file
| Record type | Advanced medical therapy research: master file |
|---|---|
| Category | Clinical trials and research |
| Retention period | 20 years |
| Disposal action | Review and consider transfer to PoD |
Clinical trials: applications for ethical approval
| Record type | Clinical trials: applications for ethical approval |
|---|---|
| Category | Clinical trials and research |
| Retention period | 5 years |
| Disposal action | Review and consider transfer to PoD |
| Notes | Master file of a trial authorised under the European portal, under Regulation 536/2014. For clinical trials records retention refer to the MHRA guidance. The sponsor of the study will be the primary holder of the study file and associated data. This is based on the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, specifically Regulations 18 and 28. |
Research: datasets
| Record type | Research: datasets |
|---|---|
| Category | Clinical trials and research |
| Retention period | No longer than 20 years |
| Disposal action | Review and consider transfer to PoD |
Research: ethics committee’s and HRA approval documentation for research proposal and records to process patient information without consent
| Record type | Research: ethics committee’s and HRA approval documentation for research proposal and records to process patient information without consent |
|---|---|
| Category | Clinical trials and research |
| Retention period | 5 years |
| Disposal action | Review and consider transfer to PoD |
| Notes | This applies to trials where opinions are given to proceed with the trial, or not to proceed. These may also have archival value |
Research: ethics committee’s minutes
| Record type | Research: ethics committee’s minutes (including records to process patient information without consent) |
|---|---|
| Category | Clinical trials and research |
| Retention period | 20 years |
| Disposal action | Review and consider transfer to PoD |
| Notes | Retention period begins from the year to which they relate and can be as long as 20 years. Committee minutes must be transferred to PoD |
Last edited: 7 May 2026 5:15 pm