Navigating the complexities of a clinical trial requires not only a deep understanding of the science but also an intimate familiarity with the tools and resources that support research excellence. ClinicalTrials.gov stands as a pivotal platform for investigators and individuals alike, offering comprehensive details about trial design, implementation, and results. The CCTS manages a ClinicalTrials.gov resource site to ensure research teams successfully navigate their commitment to scientific transparency. Whether you're an aspiring investigator, a seasoned PI looking to refine your approach, or simply interested in the behind-the-scenes of clinical trial management, the guide on this page promises to enrich your understanding and utilization of ClinicalTrials.gov. Dive into our top-10 list below to discover the pivotal knowledge and strategies that empower the best in the field to lead successful, innovative, and impactful clinical trials.
What are the top 10 things the best trial PIs know about ClinicalTrials.gov?
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1. Where to find help.
Self-help – https://www.uab.edu/ccts/clinical-research/clinicaltrials-gov
Guided help –This email address is being protected from spambots. You need JavaScript enabled to view it. -
2. When to update their record.
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.
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3. How to update their record.
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 -
4. Where to put funding information.
Protocol ID = IRB-3000#####
Secondary ID = grant/other funding information -
5. How to fully release a record.
Releasing a record is a multi-step process. Click through all steps until you get the release approval page.
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6. Respond to emails.
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.
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7. What to do if you are leaving UAB.
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. -
8. When to register a record.
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.)
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9. Who is required to input results and when.
- 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.) -
10. How to enter results.
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.)
Visit the CCTS ClinicalTrials.gov resource site for more great tips!