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 in clinicaltrials.gov.
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.
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.