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1.0 PURPOSE

This standard operating procedure (SOP) describes the procedures for the closure of research with the Research Ethics Board (REB).

2.0 SCOPE

This SOP pertains to REBs that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

The REB Chair or designee is responsible for determining if the Full Board should review any of the submitted materials.

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

The Completion of research is a change in activity that must be reported to the REB.

Although research participants will no longer be at risk under the research, a final report allows the REB to close its files and provides the REB with information that may be used in evaluating and approving related studies.

5.1    Determining when Research can be Closed

5.1.1    The Researcher may submit a research closure report to the REB when there is no further participant involvement at the site, all new data collection is complete, and the sponsor closeout activities, if applicable, have been completed;

In Clinical Trials Ontario (CTO), a Provincial Study Closure (PSC) will be processed once all Centre Study Closures (CSC) have been received and acknowledged by the Research Ethics Coordinators.
In TRAQ, a study can be closed once all the study activities, participant involvement, and data collection have been completed.

5.1.2    The responsible REB Office Personnel will review the research closure application and request any outstanding information, clarification or documentation from the Researcher if needed.

5.1.3    The REB Chair or designee will review the submission and issue a Letter of Acknowledgement to the Researcher. The research state will change to “Closed”.

5.1.4    Once a research project is “Closed” with the REB, no further submissions for that research will be permitted. However, if required, the Researcher still may submit relevant documents for acknowledgement and, if applicable, further investigation and/or action may be undertaken by the REB.

5.1.5    If the Sponsor requests additional data following the closure of the research, a request for approval shall be made to the REB, and the conditions of this request will be determined at the time of the review.

6.0 REFERENCES

See References.