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

AI Summary

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.