A temporary halt to a research study is a stoppage (suspension) which was not envisaged in the approved protocol and where there is an intention to resume the study. A study maybe halted (suspended) for various reasons such as, on the recommendation of the IDMC (i.e further to review of new safety information), as an USM, further to a serious breach, due to IMP supply issues or where recruitment has to be halted for other reasons. A temporary halt applies when the suspension is imposed on all sites; suspension of the study at a single site due to logistical reasons is not considered a temporary halt (unless the study is a single-site study).
The decision on whether a temporary halt should be imposed on a study sponsored by a Noclor partner will ultimately be Noclor’s decision (and the decision-making process should be evidenced on file).
- Notifying a Temporary Halt
For clinical trials, where it has been agreed between the Chief Investigator and Noclor that a temporary halt should be imposed on the study this should be notified to REC (and MHRA for CTIMPs) as a substantial amendment within 15 days of the decision being taken to halt the trial, according to the Noclor amendment procedures.
The Chief Investigator is responsible for notifying the local investigators/sites and any other relevant parties (such as funder) of the temporary halt. Local Investigators should be provided clear instructions as to:
- why the temporary halt has been imposed
- when the halt is to be effective from
- what the temporary halt means (is it just suspension to new recruitment or are patients on trial being suspended from treatment)
- what and how to communicate with enrolled participants and any other instructions as relevant
The Chief Investigator should request confirmation of receipt from Principal Investigator at sites that they have understood the instruction for the temporary halt (Noclor may request this confirmation evidence).
All information pertaining to a temporary halt should be retained in the Study/Trial Master File (S/TMF) and at site in the Investigator Site File (ISF).
- Re-start after a Temporary Halt
To re-start a study after a temporary halt requires a ‘re-start’ substantial amendment being submitted and approved by REC (and MHRA for CTIMPs). Other amendments to the protocol or supporting documentation may also be incorporated in the substantial amendment as required for the study to re-start (i.e a combined amendment).
The substantial amendment should be processed according to the Noclor amendment procedures.
Studies that have been on a temporary halt will require official re-activation (notice of re-activation). This re-activation notice will be issued to sites by the Noclor Sponsor Representative when the Chief Investigator has provided evidence of all required approvals/permissions (and any other information as required specific to the re-start after the temporary halt, for example, any specific instructions/re-initiation required for sites).
- When a study does not re-start
If the Chief Investigator (ultimately Noclor) decides not to recommence a study after the temporary halt, the end of study should be notified.
For Clinical Trials of Investigational Medicinal Products (CTIMPs) this would be defined as an early termination to the trial (i.e trial has ended earlier than defined in the protocol). To comply with the regulations the end of study must to be notified to the MHRA and Research Ethics Committees (REC) within 15 days of the decision being made not to re-start.