How Long do I have to Correct Errors and Problems with my ClinicalTrials.gov Records?May 5, 2022
The regulations at 42 CFR 11.64(b) specify how much time you have to correct errors and problems identified with your ClinicalTrials.gov records:
For problems in REGISTRATION submissions or updates:
- Correct or address issues within 15 days of electronic notification of the issue.
For problems in RESULTS submissions or updates:
- Correct or address issues within 25 days of electronic notification of the issue.
When a problem or error is identified, the Record Owner (i.e., the P.I., for CU records) will be notified via an email from firstname.lastname@example.org to the address associated with their ClinicalTrials.gov account. CU administrators will also reach out about record problems periodically.
If you have a problem with your record, we're happy to help you solve it! Contact email@example.com any time for help with your ClinicalTrials.gov records.
Tags: 42CFR11 clinicaltrials.gov comments FDAAA FDAAA801 Major Comment QC QC comments QC issues registration results