Tip of the Week Archive

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:

1. Keeping the record up to date
   1. Update the record at least every 12 months until the study status is changed to “Completed”, “Terminated”, or “Withdrawn” (update at least every 6 months while actively recruiting).
   2. 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).

       

2. Addressing problems, errors, and Major Issue comments in the record in a timely manner

    

3. 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:
   1. Applicable Clinical Trials (ACTs)
   2. 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)
   3. 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 clinicalresearchsupportcenter@ucdenver.edu 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 clinicalresearchsupportcenter@ucdenver.edu 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.