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Early Termination

Occasionally a research study must terminate prematurely, for example further to recommendations from the Independent Data Monitoring Committee (IDMC) over safety concerns, after a temporary halt where the decision has been made not to restart or due to poor recruitment or financial/management difficulties.

The circumstances that have led to the research terminating early will need to be documented in the Trial Master File (i.e the audit trail of decision-making). Any potential implications for participants (e.g if the study is terminating over safety grounds) and consequences to the results in terminating the trial early should be detailed in the end of study declaration form. 

The table below summarises what action should be taken in the event of a research study terminating early.

REQUIREMENTS FOR NON-CTIMPs1 REQUIREMENTS FOR CTIMPS

If the decision is made to terminate a research study before the specified date for its conclusion the Chief Investigator/ IDMC should notify the Noclor Sponsor Representative immediately (if the sponsor has not initiated the early termination).

The Chief Investigator should notify the Research Ethics Committee (REC) by submitting a Declaration of the End of a Clinical Trial form.

The Chief Investigator should notify the funder and all participating sites.

A record of the decision to terminate the trial early, the end of trial notification form and all related correspondence should be retained in the Study/Trial Master File (S/TMF).

The Chief Investigator should submit a summary study report report to the sponsor, MHRA and REC within 12 month of the declaration of end of the trial.

Chief Investigator to notify Noclor of all publications resulting from the research.

The Chief Investigator should meet the expectations of end of trial

If the decision is made to terminate a CTIMP before the specified date for its conclusion the Chief Investigator/ IDMC should notify the Noclor Sponsor Representative immediately (if the sponsor has not initiated the early termination).

The Sponsor (or  authorised sponsor contact ) will  notify the MHRA within 15 days of the date of termination (i.e 15 days of the date of decision being made) by submitting a Declaration of the End of a Clinical Trial form (CTIMP)2

The Chief Investigator must notify the Research Ethics Committee (REC) within 15 days of the date of termination by submitting a Declaration of the End of a Clinical Trial form  (CTIMP)3

The Chief Investigator should notify the funder and all participating sites.

A record of the decision to terminate the trial early, the end of trial notification form and all related correspondence should be retained in the Trial Master File (TMF).

The Chief Investigator should submit a clinical trial summary report to the sponsor, MHRA and REC within 12 month of the declaration of end of the trial.

Chief Investigator to notify Noclor of all publications resulting from the research.

The Chief Investigator should meet the expectations of end of trial 

[1] Medical Device studies - manufacturers are required to notify the MHRA when a clinical investigation comes to an end. 

[2] Once the declaration of the end of a clinical trial form has been received by the MHRA it is not possible to submit any further amendments to the trial, only the end of trial study report will be accepted.

[3] The same declaration of end of trial form should be submitted to both (authorised signatories in both E2 and E3)