Reporting Clinical Trial Results to ClinicalTrials.gov

Required Results Reporting

Federal regulations and the NIH policy require reporting of results for Applicable Clinical Trials (ACT), Probably Applicable Clinical Trial (pACT) and NIH funded clinical trials. The Responsible Party is required to report results information for a registered clinical trial no later than one year after the Primary Completion Date identified in the registration record.

The Primary Completion Date is the “date the last subject was examined or received an intervention to collect final data for the primary outcome measure” of the study.  The PI and/or study statistician should be involved in preparing results for reporting to ensure the information is accurately summarized and in the format required by law.

What Must be Reported

Results are submitted as four separate modules:

  1. Participant Flow: A tabular summary of the progress of participants through each stage of the study, by study arm or comparison group.
  2. Baseline Characteristics: A tabular summary of the data collected at the beginning of a study for all participants, by study arm or comparison group, such as demographics and baseline data.
  3. Outcome Measures and Statistical Analysis: A tabular summary of outcome measure values, by study arm or comparison group, including tables for each prespecified Primary and Secondary Outcomes.
  4. Adverse Events: A tabular summary of all anticipated and unanticipated Serious Adverse Events and a tabular summary of anticipated and unanticipated other adverse events exceeding a specific frequency threshold.

How to Report Results

  1. Login to the ClinicalTrials.gov PRS and open the applicable study record
  2. Click “Enter Results”
  3. Complete all required and optional data elements
  4. Upload supplemental documentation
    1. Full study protocol
    2. Statistical analysis plan, if separate from the protocol

    Documents need to be the most recent version reviewed by the IRB and include a cover page with the official title of the study, the NCT number, and the date of the document. The Responsible Party may redact the following from the protocol prior to results submission:

    • Names, addresses, and other personally identifiable information
    • Trade secret and/or confidential commercial information
  5. Release the record and verify that the status changes to “Released”
  6. Monitor the record for any comments from PRS staff that need to be addressed

Frequently Asked Questions

Who can help me register my study?

Campus Units
Office of Research Support & Compliance Quality Program
orsc@uts.cc.utexas.edu
512-471-8871

Dell Medical School
Research Operations Team
dellmedctgov@austin.utexas.edu

What do I have to include in my informed consent form if my study is registered?

Applicable Clinical Trials (FDA)
The following language must be inserted into informed consent forms verbatim:

“A description of this clinical trial will be available on https://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.”

NIH and Other Sponsors
NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017). Use the following language:

“This trial will be registered and may report results on https://www.ClinicalTrials.gov, a publicly available registry of clinical trials.”

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