Trial does not Recommence follows the Temporary Halt or Early Termination station and precedes the End of trial Declaration station. This process occurs in parallel with Safety Reporting, Progress Reporting and Ongoing Management & Monitoring. It also has the potential to occur simultaneously with an MHRA Inspection, Audit, Substantial Amendments, Addition of New Sites & Investigators, and Temporary Halt or Early Termination. If the trial does not recommence, it is a legal requirement relevant to all trials.
If the sponsor decides not to recommence the trial after halting it, they should notify the competent authorities (MHRA in the UK) and ethics committees of all member states concerned. The ‘Declaration of the End of a Clinical Trial’ form should be used which can be accessed in Chapter 1 of the Eudralex Volume 10 Clinical Trials Guidelines.
A covering letter should be sent that identifies:
- The protocol
- The protocol code number
- The Investigational Medicinal Product (IMP)
- The EudraCT number.
The letter should provide a brief explanation of the reasons for not recommencing the trial. This notification must be provided within 15 days of the decision not to recommence.
NHS R&D offices and any participating sites will also require notification in accordance with local policies/procedures.
The Funder should be informed of all developments and decisions as soon as possible.
For non-CTIMP research, the Chief Investigator should notify the ethics committee using the end of study form specified on the HRA website.