At minimum, all records are required by FDAAA/NIH to be updated annually or as changes occur to the protocol or enrollment dates. Delaying updates could affect study enrollment and/or future funding.

Study information – updates to the protocol should be updated on CT.gov , as needed.
Study status – verification date, study start and study end dates when they change
Changes to PI, Record Owner, and/or Responsible Party as soon as they occur

Protocol ID = IRB-3000#####
Secondary ID = grant/other funding information

Releasing a record is a multi-step process. Click through all steps until you get the release approval page.

Addressing a CT.gov request is usually a quick and simple task, so please respond to our requests for updates or to our questions for you. We provide step-by-step instructions to complete your update or to address your errors. It helps if you can notify us when you are having any issues with your study so we can help you resolve them quickly.

Send an email to This email address is being protected from spambots. You need JavaScript enabled to view it. to discuss options for your record if you are leaving UAB.

This can be tricky if you are waiting on a grant. It is usually best to register a study with the IRB, enter ‘pending’ where it asks for the NCT number, then submit to CT.gov. By the time you get your IRB pre-review back, you should have your NCT number.

(Tip: We can review your record prior to submission to the PRS to check for commonly flagged areas, so that your NCT number will not be delayed.)

• If your study is funded in any way by NIH, results are required no more than one (1) year after the Primary Completion date.
• If your study is categorized by FDAAA as an ACT/pACT, results are required no more than one (1) year after the primary completion date.
• If your study is not funded by NIH or is categorized by FDAAA as a non-ACT, then results are voluntary unless you have noted in your protocol that you will submit results.
• If you fail to report results on time, you may be listed on one of the agencies’ non-compliance trackers. Once you are listed on a non-compliance tracker, there is no way to remove yourself. This could affect your future funding opportunities.

(Tip: Mark your calendars for your study end dates. If you close out in IRAP or with your grant, start preparing for results submission.)

We have tools to help you enter results at https://www.uab.edu/ccts/clinical-research/clinicaltrials-gov, or email This email address is being protected from spambots. You need JavaScript enabled to view it. to schedule a guided entry process via zoom, where you share your screen and enter your results in real time.

(Tip: Give your outcome measures from CT.gov to your statistician. Some studies alter what is submitted for publication, but you will need to answer the outcome measures you told the PRS you would.)