Closure
It is the IRB’s expectation that all concluded studies will be officially closed with the IRB.
This applies to exempt research, expedited research that does not require continuing review, student research, internally funded studies as well as industry sponsored clinical studies.
When May a Study Be Closed?
The IRB considers a study concluded when the following conditions are met:
- All participants have completed all research related visits and procedures
- There is no further contact with participants needed for reasons related to research
- Any data sets under analysis for manuscript and publication writing have been stripped of all identifiers and further access to identifiable subject data is no longer required, and
- If the study is investigator-initiated and posting on clinicaltrials.gov was required: the results have been posted on clinicaltrials.gov and a copy of the confirmation that results were received is being submitted to the IRB.
How To Submit A Closure Request
Step by step instructions on how to submit your closure request in eIRB.
- Go to eIRB.
- To request a closure request, scroll to the top of your protocol in eIRB and look for a series of blue boxes and select the “Initiate Closure” box and select “Close”
- The Closure Form will appear and be sure to read the instructions enclosed in the blue box.
- Complete the questions in the form. Note that certain responses may warrant a warning that closure is not appropriate at this time. (i.e. outstanding billing)
- Once you have completed the form without receiving a warning message, be sure to check the “ATTESTATION” box.
- To continue click “Save” in the bottom right corner of the e-form.