# Clinical trials for medicines: Archiving and retention of clinical trial records

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/e5c50daa-eb3d-4666-857f-4e2f8d266ab0
Type: Guidance
Published: January 12, 2026
Updated: April 27, 2026

> This guidance, fully effective as of 28 April 2026, outlines the mandatory requirements for archiving and retaining clinical trial records under the updated Clinical Trials Regulations framework. It specifies the responsibilities of sponsors and investigators in maintaining essential documentation, such as trial master files, investigator site files, and case report forms, to ensure compliance with Good Clinical Practice (GCP). The document emphasizes that proper record-keeping is vital for safeguarding data integrity and facilitating the long-term verification of trial results. Key requirements include a minimum retention period of 25 years after a trial's conclusion. Organizations must implement secure storage environments with controlled access to protect against unauthorized changes or accidental destruction. Additionally, electronic records must be managed to ensure their authenticity and reliability throughout the storage period. The guidance also mandates clear, formal agreements between sponsors and investigators to delineate specific archiving duties. By following these protocols, stakeholders ensure that trial data remains accessible and verifiable for future regulatory reviews.

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## Content

The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft. The guidance outlines the responsibilities for archiving and retaining clinical trial records to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements. Sponsors and investigators must maintain essential documents that demonstrate the trial was conducted according to protocol and regulations. These records include trial master files, investigator site files, and supporting documentation such as informed consent forms and case report forms. Proper archiving safeguards data integrity and enables verification of trial conduct long after completion. Retention periods are defined by law and vary depending on the type of trial and applicable regulations, but generally, records should be kept for at least 25 years after the trial ends. Sponsors must ensure secure storage, controlled access, and protection against unauthorised alteration or destruction. Electronic records should meet standards for authenticity and reliability, and any transfer of records must preserve their integrity. The guidance emphasises that clear agreements between sponsors and investigators are essential to determine who is responsible for archiving and maintaining these records.

## Attachments

- [Archiving and retention of clinical trial records](/government/publications/clinical-trials-for-medicines-archiving-and-retention-of-clinical-trial-records/archiving-and-retention-of-clinical-trial-records)