Maintaining & Updating ClinicalTrials.gov Records

Required Updates to a ClinicalTrials.gov Record

In general, the Responsible Party must review and update, as necessary, an active study record at least once every 12 months. Failure to do so will result in the record being identified as having a problem that needs to be addressed.

Federal policy further requires that some elements be updated more often, as summarized in the table below. In addition, federal policy requires that if a protocol is amended in such a manner that changes are communicated to human subjects, updates to any relevant clinical trial information must be submitted no later than 30 calendar days after the amendment is approved by the IRB. More information is available at: https://clinicaltrials.gov/ct2/manage-recs/how-edit.

Data ElementDeadline for Updating
(all days are calendar days)
Study start date30 days after the 1st subject is enrolled (if the 1st subject was not enrolled at the time of registration)
Intervention name(s)30 days after a nonproprietary name is established
Availability of Expanded Access30 days after expanded access becomes available (if available after registration); and 30 days after an NCT number is assigned to a newly created expanded access record
Expanded Access status30 days after a change in the availability of expanded access
Expanded Access type30 days after a change in the type(s) of available expanded access
Overall recruitment status30 days after a change in overall recruitment status
Individual site status30 days after a change in status of any individual site
IRB review status30 days after a change in status
Primary completion date30 days after the trial reaches its actual primary completion date
EnrollmentAt the time of the primary completion date is changed to “actual” the actual number of participants enrolled must be submitted
Study completion date30 days after the clinical trial reaches its actual study completion date
Responsible Party, by official title30 days after a change in the responsible party or the official title of the responsible party
Responsible Party contact information30 days after a change in the responsible party or the contact information for the responsible party
Device product not approved or cleared by the US FDA15 days after a change in approval or clearance status has occurred
Record verification dateAny time the responsible party reviews the complete set of submitted clinical trial information for accuracy and not less than every 12 months, even if no other updated information is submitted at that time

Source: US Department of Health and Human Services, https://prsinfo.clinicaltrials.gov/FinalRuleChanges-12Dec2016.pdf

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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