Close Out Study

Close Out Study

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, please review the IRB-HSR website.  You may also contact the SOM CTO at 434-924-8570.

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.

Closing Your Study with the IRB-HSR

Please refer to the IRB-HSR website for guidance on closing your trial with the IRB-HSR.

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.

Here is a exit checklist provided by the UVA Provost.

Records Management/Retention

Please refer to the University of Virginia Records Management policy and storage standards for proper records management and retention.

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.