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Submit a Study Closure
A study may be closed when a) the research is permanently closed to enrollment, b) all participants have completed all research-related interventions/interactions, c) collection of private identifiable information is complete, and d) analysis of private identifiable information is complete. Continued IRB approval is not required when the remaining study activities are limited to analysis of de-identified data and/or manuscript preparation.
In addition, when the PI identified in CATS IRB leaves the University, the study should be closed with the Penn State IRB or another person at Penn State must take over the role of PI and submit a modification to the IRB for approval.
Graduate student PIs should close their studies prior to graduation.
Submitting a Study Closure
To begin a study closure, follow the steps outlined below:
- Login to CATS IRB using your PSU access account.
- Click “IRB” from the top tab menu.
- Select the desired study be clicking on the “Active study” tab and clicking on the study name.
- Click “Create Modification/CR” on the left side of the screen and then select “Continuing Review.
5. Under “What is the purpose of this submission?” choose the “Continuing Review” option to begin the study closure.
6. On the “Research milestones” of the Continuing Review/Study Closure Information page, check the first four research milestones (see screenshot below).
When the first four milestones are checked, an “I acknowledge this study will be closed” checkbox appears in the form and must be checked. Any open (not yet approved) modifications must be approved or discarded.
7. Complete the form and submit for IRB review by following the remaining instructions.
Note: Only the Principal Investigator (PI) or PI Proxy can submit the study closure.
Answer the remaining questions and submit the Continuing Review. After completing these steps, the IRB will review the information provided and notify you of study closure.
See Also
Office for Research Protections
Address
200 Innovation Blvd.
Suite 110
University Park, PA 16802
The Office for Research Protections (ORP) ensures that research at the University is conducted in accordance with federal, state, and local regulations and guidelines that protect human participants, animals, students, and personnel involved with research.