Responsibilities of Record Owners after RegistrationFeb 4, 2021
ClinicalTrials.gov record owners (the study P.I. for CU investigator-initiated studies) are responsible for maintaining study records in compliance with federal regulations and University and institutional policies. These responsibilities include:
- Keeping the record up to date
- Update the record at least every 12 months until the study status is changed to “Completed”, “Terminated”, or “Withdrawn” (update at least every 6 months while actively recruiting).
- Some changes require more rapid updates. Refer to Table. Clinical Trial Registration Data Elements for More Frequent Updating for a list (where required, updates must usually be made within 30 days of a change).
- Addressing problems, errors, and Major Issue comments in the record in a timely manner
- Reporting study results, if required, within 12 months of the study Primary Completion Date (usually the last study visit). Results are required to be reported to ClinicalTrials.gov for:
- Applicable Clinical Trials (ACTs)
- All clinical trials (including behavioral and phase 1 trials) that receive NIH support if the trial started and the grant application (or competing renewal) was submitted after 1/18/2017 (per NIH policy)
- As required by the policies of other supporting agencies.
The CRSC has plenty of resources to help you keep your record tidy!
- Visit our ClinicalTrials.gov support page to find guidance documents, FAQ, and archived Tips of the Week.
- Download our step by step guide for record registration and maintenance.
- Contact email@example.com at any time for answers to your ClinicalTrials.gov questions or help responding to PRS comments.
- Record owners can add their coordinators and study team members to the record Access List (or contact firstname.lastname@example.org with the P.I. name and the COMIRB #). Anyone on the record Access List will be able to edit and update the record.
- Attend a CTSA class on ClinicalTrials.gov. Small teams and individual training can be scheduled upon request.
Tags: 42CFR11 clinicaltrials.gov FDAAA801 record owners registration requirements responsible party results