Once a project has been closed at a site, i.e. no further contact with participants required and no further access to source data/medical record required, a Site Closure Report must be submitted to the Ethics Committee.
When the overall project is closed at all sites included under the Ethics Committee approval a Final Report must be submitted.
Final/Site Closure Reports should be submitted by:
- MULTI-SITE ETHICAL REVIEW: Sponsor or Coordinating Principal Investigator or Principal Investigator (or delegate), to submit a Site Closure Report on behalf of a site.
- MULTI-SITE ETHICAL REVIEW: Sponsor or Coordinating Principal Investigator (or delegate) to submit a Final Report on behalf of all sites included under the Ethics Committee approval.
- SINGLE SITE ETHICAL REVIEW: Sponsor or Principal Investigator (or delegate) to submit a Final/Site Closure Report.
PROCEDURE FOR SUBMITTING YOUR FINAL/SITE CLOSURE REPORT
The report must be submitted using the Project final report/ Site closure report . Email an electronic copy to [email protected] including the Project No. and the term ‘Final Report’ in the subject line of the email.
These items will be acknowledged.