Reference:GBR HRA - Ending your project 28-Jan-2025 -

Document information
Reference	GBR HRA - Ending your project 28-Jan-2025
Validity area	GBR
Scope(s)	G
Document name	HRA - Ending your project
Version / Revision	28-Jan-2025
Status	Current
Document type	Official recommendation
Language(s)	EN
Description	HRA - Ending your project
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 6 — Unit 6.4.2
Scope	G
Document part	-
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Sponsor final report, Ethics committee, MHRA, Trial end, Clinical study report

Content

HRA (England) website: https://www.hra.nhs.uk/approvals-amendments/managing-your-approval/ending-your-project/

Final report on the research Once you have declared the end of study, and notified the relevant review bodies as described above, you may need to submit a final report of the research.

Final report to the Research Ethics Committee (REC) All project-based research (not research tissue banks or research databases) that has been reviewed by a REC, needs to submit a final report. This report should be submitted to the research ethics service within 12 months of the end of the study.

It you submitted via combined review, you should complete and submit the final report form in the new part of Integrated Research Application System (IRAS).

All other project-based research reviewed by a REC, should use the webform on the our website. There is no need to submit a CSR to the REC for any CTIMP. The information relevant for the REC is captured in the final report form.

Final Report to the MHRA (medical devices) If your study was a clinical investigation of a medical device , you should send a copy of the final report to the MHRA when it is available.

Final Report to other review bodies You should check the final report requirements with any other review bodies that reviewed or approved the study.