End of Trial Procedures

At the end of a trial, there is a formal process that needs to be followed to close down all participating sites, and to notify the approval bodies that the trial has come to an end.

The final trial data set will need to be checked and prepared for analysis, and the trial documentation will need to be checked for completeness and prepared for archiving.

The ‘End of Trial’ is formally defined in the trial protocol. It is a date that will take into consideration the time required to collect all the data needed to answer the research question. The end of trial date may therefore be the last treatment visit for the last participant recruited into the trial, but may also include a period of follow up, and this date will therefore be specific to each protocol. Regulatory authorities and Research Ethics Committees (REC) need to be informed when a trial has come to an end and there are likely to be stipulations specific to the country in which you are conducting your research regarding the timelines for these notifications to be made. For example, in the UK, for a clinical trial of an investigational medicinal product (CTIMP), there is a legal requirement to notify the Medicines and Healthcare Products Regulatory Agency (MHRA), and REC within 90 days of the end of the trial.

Sometimes there may be reason to end a trial earlier than the end date defined in the trial protocol. This may be because of poor recruitment or there may be safety or efficacy concerns that have been identified by the Data Monitoring Committee (DMC), who may recommend that the trial should be terminated early. Where a trial is terminated early, the relevant authorities will need to be notified and the timeframe for this might vary. For example, in the UK if a trial were to terminate early, the MHRA and REC would need to be notified within 15 days of the end of the trial. The definition of early termination of a trial does not include trials that complete early because full recruitment has been achieved earlier than anticipated. When notification is made of an early termination of a trial, the relevant authorities will need to be informed of the reasons for the early termination.

In addition to notifying the relevant authorities of the end of trial, there will need to be a formal closure of the trial sites that have recruited participants for the trial. This will include the process of ensuring all trial related activities at the site are reconciled and/or complete. Formal closure is a process that will include consideration for the following (please note some considerations are only applicable to certain types of trial, for instance, drug accountability will only be applicable to a trial that has involved an Investigational Medicinal Product):

Ensuring the Trial Master File (TMF) and Investigator Site File (ISF) are complete and any parts of the ISF that may have been kept elsewhere during the course of the trial (for example a pharmacy file) are reconciled with the main ISF.
Data collection is complete, all Serious Adverse Events and any data queries have been followed to resolution.
Any issues that have been flagged up during previous quality checks (for example monitoring) have been followed up to resolution.
All drug accountability is complete and any outstanding Investigational Medicinal Product (IMP) has been returned to the trial site and destruction of the IMP has been conducted in compliance with the requirements of the protocol.
Any trial supplies and/or equipment have been collected.
Any trial samples and associated documentation have been reconciled.
All financial matters are resolved and all site payments are complete as agreed and documented in trial-related contracts/agreements/approvals and/or sponsor requirements.
Any code break envelopes maintained at site are reconciled.

Once all the activities related to site closure have been completed, the sponsor (or trial management team on behalf of the sponsor) should write to the site to confirm closure. The site should also be reminded of the requirement to archive all trial documents for the period specified and made aware of the study publication policy, as documented in the protocol and/or contracts/agreements.

An end of trial report should document whether the trial achieved its objectives, the main findings, and arrangements for publication or dissemination of the research, including any feedback to participants. This report should be sent to the REC (and in the UK the MHRA for CTIMPS) within 12 months of the end of the study. A summary of the end of trial report should be sent to sites that have participated in the trial (once the trial is closed at all sites).

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