Human Research Protection Program

ClinicalTrials.gov Support

Overview

What

ClinicalTrials.gov (CT.gov) is a federally mandated clinical trial registry & results database run by NIH that disclose key information of clinical trial to general public. Goal is to increase transparency and reduce publication bias. Basic functions are study registration, annual updates, modification, and results reporting.

Why

  1. Required by Law
  2. Required by National Institute of Health (NIH)
  3. Required by Centers for Medicare & Medicaid Services (CMS)
  4. Required for Journal Publication

*Failure to comply may results in public notices of noncompliance and violations, FDA sanctions, civil monetary penalties ($12,103 per day), withholding of grant funds, refusal to CMS claims and journal publication.

Which

Please use a CT.gov Determination Flow Chart for identification of CT.gov reporting required study

When

Registration: At the time of eIRB study submission

Annual Updates: At a minimum, at once every 12 months

Modifications to Study:

  • Within 15 calendar days after changes of:
    • Device approval/clearance status
    • Actual primary completion date
  • Within 30 calendar days after changes of:
    • IRB status
    • responsible party and/or contact information
    • overall recruitment status
    • primary completion date & study completion date
    • Protocol changes that impact registration information
    • study start date
    • intervention name
    • availability expanded access
    • expanded access status/type
    • individual site status

Results Reporting: Within 12 months after the primary completion date*

See eIRB and CT.gov clinical trial reporting timeline

Who

Data Entry: Anyone on the study team
Record Submission: Responsible Party (PI)

How

  1. Determine whether trial requires registration/result posting
  2. Decide Record Owner & Responsible Party (PI)
  3. Obtain Protocol Registration and Results System (PRS) account
  4. Log in to PRS
  5. Create a new record & Enter study information
  6. PI Approve/Release (submit) record to CT.gov for PRS review
  7. CT.gov PRS review
  8. Address requested changes within 15 calendar days
  9. Record is public
  10. Keep record up to date (Annual Updates)
  11. Enter results if required.
  12. PI Approve/Release to CT.gov for PRS review
  13. CT.gov PRS will review
  14. Address requested changes from PRS within 25 calendar days
  15. Results are public

Services Provided

UTSW RSO will assist the UTSW/Parkland research community with CT.gov registration, results reporting, and updates. If you have questions or need assistance, please ctgov@UTSouthwestern.edu. 

Researcher Responsibilities

  1. Request a CT.gov account
  2. Provide outcome measures + description
  3. Provide summary results for pre-specified primary and secondary outcomes with appropriate unit of measure and precisions
  4. Provide adverse events
  5. Submit record to CT.gov