Principal Investigators have the responsibility of informing the IRB when a protocol has been completed. This requirement is for any study that initially underwent full board, expedited or exempt review.
A protocol is considered to be open and active until the investigator has notified the IRB the study has been completed. For studies reviewed by the full board or expedited review process this notification includes the submission of a Protocol Closure Form to the IRB. For a study that was granted an Exempt Determination, an email to IRB staff will suffice.
Investigators will be notified by the IRB at least annually following the initial approval of the research via a Continuation Status Report, an IRB Update Form or an email for an Exempt study. At these notification intervals, investigators must submit the form sent to them, a closure form or for Exempt studies an email notification to IRB staff.
Faculty advisors for student research have the obligation to ensure that the Protocol Closure Form is filed with the IRB in a timely fashion.
When a principal investigator terminates employment or other association with UVA, he or she is obligated to submit a Protocol Closure Form to the IRB or formally transfer the protocol to another principal investigator via a modification which is reviewed and approved by the IRB. In very rare cases, the IRB may grant special permission for the departing individual to remain as principal investigator on the protocol. Cases are reviewed on a case by case basis.
A protocol may be closed when all of the following apply:
- All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing)
- All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained)
- No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary)
- Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable data is no longer necessary. Note: this includes review of source documents by study sponsors.
Complete the Protocol Closure Form and submit it to the IRB within 30 days of closure of the protocol. In order to close your IRB protocol officially, submission of the Protocol Closure Form is required for all studies reviewed by the expedited or full board review process.
For studies determined to be exempt from IRB review, the study team does not need to complete a Protocol Closure form but must send an email to the IRB notifying them the study has been closed.
No closure documentation is required for projects determined to be Non-Human Subject Research, Coded Research or Non-Engaged Research.
Record Retention
For questions regarding how long one must keep records, see Record Retention Requirements
Use of Data/Specimens in Future Research
If you think you may want to use the data/specimens in future research there are additional steps that must be taken. See: How to keep data or specimens for future research after original study under which they were collected is closed
FDA Regulated Studies:
Closing Your IND or IDE
For guidance on closing out your IDE, please review 21 CFR 812.140.
For guidance on closing out your IND, you may also contact the SOM CTO at 434-924-8570.
Also, Please refer to 21 CFR part 312.62 for retention requirements for an IND trial and 812.140(6)(d) for IDE trial record retention policies.
Closing Grants Which Funded this Protocol
If the PI on the Grant/ Proposal is a UVA faculty member and the grant is also being closed submit the Grant Closure Form to the IRB-HSR.
Closing Your Study with clinicaltrials.gov
The responsible party or study record owner should ensure the status is updated with clinicaltrials.gov. If applicable, study results may be required to be entered here.
Please refer to FDAAA 801 requirements for additional information.
Storage Locations
Please refer to the University of Virginia Records Management policy and their guidance on proper & approved storage locations for your records.
Leaving UVA
If you are involved in research at UVA and you will be leaving UVA, there are some steps you will need to take prior to your departure.
If you are leaving UVA, you are strongly encouraged to utilize the Exit Checklist.