Notifying end of research
IRAS will send you an email, reminding you to notify us about the end of your trial, 30 days before the proposed study end date. If the proposed study end date you previously entered is not correct, you can change this by completing an amendment (visit Amendments for further information).
The End of Trial form is completed over a period of time and is a three-step process. It involves:
Step 1: Notifying End of Trial (EOT)
Before completing the EOT report make sure that all outstanding tasks on the project (such as amendments, USM or DSUR reports) are completed or closed. You will not be able to submit the EOT notification until this is done.
It is important to only declare the end of trial once it has actually ended. If you submit the EOT notification ahead of time, you won't be able to make any further changes to the project in IRAS.
To notify the End of Trial go to 'My Projects' and open the project you wish to submit a report for.
Select the 'Reporting' button from the top right side of the screen.
You should then select the type of report you wish to make from the drop-down list. In this case select 'End of Trial (EOT)'.
Once created, this form is accessed via 'Reports' (not via 'My Tasks' or 'My Organisational Tasks'). You'll be asked to enter details of the applicant submitting the report, whether the study is UK only or international, and provide the study end date. You will also be asked to specify if it's an early termination.
For UK only trials, the only date to complete will be the global end date.
For international trials, you can provide both the UK end date and the global end date. You can submit the UK end date first, and then submit the global end date at a later point. This will notify the REC that the trial has ended in the UK. You'll still be able to make amendments, such as changes related to the conduct of the trial outside the UK, that require notification to the MHRA.
Step 2: Submitting the Clinical Summary of Results (CSR)
Once the EOT notification is received and acknowledged the project status will change to 'Awaiting Summary Report'. You will then be able to submit the clinical summary results. You can upload this as a document or provide the URL if the clinical summary results are available online (clinical summary results are submitted to the MHRA only).
After you've submitted this, the MHRA will need to acknowledge its receipt before the status in IRAS is updated to 'completed'.
You have up to 12 months (or 6 months for paediatric trials) after the trial has ended to submit the clinical summary of results.
If the MHRA have any queries about the EOT report, they may raise a request for information (RFI) in the system. You can respond to these in IRAS (visit Responding to Requests for further details).
Step 3: Submitting the Final Report
A reminder will be sent to you one month before the final report deadline. This deadline will be 12 months (or 6 months for paediatric trials) after the trail has ended. Refer to our page on submitting the final report for detailed instructions.