Study Closure

A closed study is defined as one where the following is true for all Unity Health Toronto sites:

  • All participant involvement is complete.
  • All data collection is complete.
  • All data clarification is complete.
  • All data transfer is complete.
  • All access to the participants’ medical records is complete.
  • The clinicaltrials.gov registration has been updated and study team will post summary results within the required timelines.

If your study meets the above criteria, please follow these instructions to close your study:

Submit completed study closure form

  1. Complete the study closure form in full, with an original signature of the Unity Health Lead Applicant. In lieu of an original signature, the submission email can be sent by the PI or by a research team member with the PI cc’d.
  2. Submit an electronic copy of the complete submission to researchethics@unityhealth.to, with the subject line “REB <REB Number> – Study Closure”. Incomplete forms will not be accepted.

Review of study closure package by the Research Ethics Board

  1. Study closures are reviewed on a first-come, first-served basis. 
  2. The contact person for the closure will typically be the Research Ethics Coordinator that worked on the original application. If you don’t have a Research Ethics Coordinator, please email researchethics@smh.ca.
  3. If there are any final questions or clarifications required, the Research Ethics Coordinator will contact you.

 

Approval of the study closure application

  1. Once the review is complete and any concerns have been addressed, the study will be closed. The closed study file will be archived off-site.
  2. The closure letter will be sent to you via email.

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