Temporary Halt or Early Termination

Temporary halt or early termination

A temporary halt of a trial is a stoppage of the trial which is not envisaged in the approved protocol and where there is an intention to resume it.

When a trial is temporarily halted, the competent authorities (MHRA in the UK) and ethics committees of all member states concerned must be informed within 15 days of the halt. This notification should be in the form of a substantial amendment. Please refer to the MHRA web page for notification details and requirements for recommencing a trial.

If a trial is terminated early; before the date specified for its conclusion*, the sponsor should notify the competent authorities (MHRA in the UK) and the relevant ethics committees within 15 days of the date of termination by submitting a ‘Declaration of the End of a Clinical Trial’ form which can be accessed in Chapter 1 of the Eudralex Volume 10 Clinical Trials Guidelines.

*Note: an earlier end of the clinical trial, which is not based on grounds of safety, but on other grounds, such as faster recruitment than anticipated, is not considered an ‘early termination’.

The sponsor should clearly explain the reasons for the temporary halt or early termination, and describe follow-up measures, if any, that are taken for safety reasons. A notification of substantial amendment should be submitted alongside declaration of early termination where necessary, to seek ethical review of related actions e.g. informing participants, continuity of care and follow-up.

It is also important that there is clear documentation in the Trial Master File about the decision to temporarily halt or terminate a trial early.  This documentation should include a clear justification and rationale for the decision, made by the appropriate personnel, which provides the evidence basis for the relevant submissions.

NHS R&D offices and any participating sites will also require notification in accordance with local policies/procedures.

For non-CTIMP research, the Chief Investigator should notify the ethics committee as per the requirements and forms specified on the HRA website.

The Funder should be informed of any such developments as soon as possible.

Further reading: