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GuidanceMHRA

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

Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.

First published: Jan 12, 2026Last updated: Apr 27, 2026Changes: 5

Latest change: 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 full document, source attachments, and change history are available on KeyPedia. Sign in to view.

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