Closing a Study

Once there is no further participant involvement at the research site, all new data collection is complete, and the sponsor conducts the appropriate closeout activities (if applicable), the Researcher can submit a request for study closure to HREBA.

  

Submitting a Closure

For studies currently in paper format, a request for study closure must be submitted to the Committee using the Site Closure – Study Completion Form, accompanied by all appropriate supporting information.  You will get a formal response from HREBA, either approving the study closure or requesting additional information.

For studies that use the IRISS electronic platform, study closures must be completed using the IRISS system.  You will receive an email indicating that your closure request has been submitted, and will be contacted further, only if additional information is required.

 

PDF Document: 406 Guidance for Closing a Study