Principal Investigators have the responsibility of informing the IRB when a protocol has been completed.
A protocol is considered to be open and active until the investigator has submitted a Protocol Closure Form to the IRB.
Investigators will be notified by the IRB at least annually following the initial approval of the research. At these notification intervals, investigators are to submit either a continuation request or a Protocol Closure Form.
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:
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. No documentation is required for projects determined to be Exempt, Coded, Non-engaged or not involving research with human subjects.
For questions regarding how long one must keep records, see Record Retention Requirements
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
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.
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.
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.
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.