Trial End
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Trial Completion
Trial completion or end of a trial is normally considered as the date when the last patient has their last visit (of all sites, if a multi-site trial). The definition of end of a trial must be clearly described in the protocol. The Chief Investigator must notify the MHRA and REC (with a copy to CTRG) and relevant R&D department(s) (if applicable) within 90 days of the end of the Clinical Trial by completing the End of Trial Form. A final DSUR may be sent at the same time or on the next due date.
Archiving/Publication
In line with the Medicines for Human Use (Clinical Trials) Amendment Regulations 2006, the University of Oxford requires that all essential documents be retained for at least 5 years after the completion of a Clinical Trial or for a longer period where so required by other applicable requirements e.g. genetic studies. If the Clinical Trial involves minors under 18 years old, essential documents should be archived until 3 years after the youngest subject reaches 18 years old, or 5 years after the conclusion of the trial, whichever is longer. Please see our SOP Template for Archiving of Essential Documents 
(55kb).
Final Report and Publication
The publication policy of a Clinical Trial should be addressed in the protocol, a written agreement or a departmental SOP.
The Chief Investigator must provide a summary of the Clinical Trial report within one year of the end of the trial to the REC and MHRA; this should be copied to CTRG. A Final Report Template (42kb) is available for use. The University is called upon occasionally to provide reference to recent publications. Please inform CTRG of the reference when your paper is accepted for publication.