Final Trial Management Records (formerly Final Trial Management Documentation)
Trial Approvals Phase
Final Trial Management Records follows the Permissions & Approvals Obtained station and precedes either the Trial is Abandoned or Trial Begins stations. This is a legal requirement which is relevant to all trials. This station is part of the 'trial approvals phase' group of stations.
Final Trial Management Records
The Chief Investigator (CI) should ensure that all essential trial records are prepared, version-controlled, and, where relevant, distributed to each trial location before the trial begins at that location. As the trial progresses, the CI should ensure that new and updated records are appropriately managed and that each trial location retains relevant superseded documents to support full reconstruction of the trial. For Clinical Trials of Investigational Medicinal Products Appendix C of ICH E6 (R3) (.PDF) provides examples of the types of records that should be considered essential.
Essential records in the Trial Master File (TMF) and Investigator Site Files (ISFs) have clear version control and traceability over time. Where documents are updated, superseded versions should be retained as appropriate, together with an audit trail of changes, approvals and implementation dates. This supports transparency and allows the development, management and conduct of the trial to be reconstructed in context.
Retention of the TMF
By the end of the trial, the TMF should provide a complete record that enables an independent party (e.g., inspector or auditor) to reconstruct the trial's design, conduct, monitoring, and reporting.
The amended Clinical Trials Regulations require the retention period for the archive of the TMF to be at least 25 years. Sponsor must also appoint a named individual within the organisation responsible for archiving records from the TMF. Access to these records must be restricted to this appointed individual, auditors and inspectors.
Further Reading
- European Medicines Agency (EMA) (.PDF): Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 6 December 2018 (PDF).
- Health Research Authority: Prepare study documentation.
- Trial Documentation station.
- Archiving station.
Note: The NIHR Clinical Trials Toolkit has been updated to reflect the amended Clinical Trials Regulations, which took effect in the UK on 28 April 2026. Content and terminology has been updated across the CT Toolkit site, however the interactive routemap is still in the process of being updated accordingly.