Trial is Abandoned
Trial Approvals Phase
The Trial is Abandoned station follows the Final Trial Management Documentation station. Abandoning the trial is a good practice process which can be relevant to all trials. This station is part of the 'trial approvals phase' group of stations.
Trial is Abandoned
A clinical trial is generally considered to have begun when trial-related procedures described in the protocol, such as participant screening or obtaining consent, are initiated.
In the UK, if a sponsor decides to abandon a trial before it has commenced, the Chief Investigator or sponsor must notify the Research Ethics Committee (REC) in writing, outlining the reasons for the decision. The HRA’s step-by-step guidance provides more information on withdrawing a submission. Where applicable, the Medicines and Healthcare products Regulatory Agency (MHRA) should also be informed. Other relevant bodies, such as local NHS R&D offices, must also be notified.
Funders should be informed of the decision to abandon the trial and of any subsequent developments. They will advise on their specific notification, reporting, and close-out requirements, which may vary by funding body.
Lapse of a Clinical Trial Approval
Under the amended Clinical Trials Regulations, a clinical trial approval will lapse two years after the approval date if no participants have been recruited. The MHRA monitors the approval status and requires the sponsor to inform them when the first participant is recruited.
The MHRA will notify the sponsor if a lapse has occurred, enabling the sponsor to submit an end-of-trial report. Sponsors may, however, apply for extensions, with details available on the MHRA website.
Further Reading
- Temporary Halt station.
- Early Termination station.