Clinicaltrials.gov

ClinicalTrials.gov FAQs

• Which Trials Must be Registered at ClinicalTrials.gov?

  • By law, studies that meet the definition of “Applicable Clinical Trial,” which is defined in the ACT checklist at this link
  • Per NIH policy, studies that receive NIH funding and that meet the NIH definition of “clinical trial,” which is defined on the NIH website at this link
  • Per the International Committee of Medical Journal Editors (ICMJE) guidelines, studies that will be published in journals that follow the ICMJE guidelines and that meet the ICMJE definition of “clinical trial,” which is defined on the ICMJE website at this link

• For Which Trials Must Results be Reported at ClinicalTrials.gov?

  • Studies that are required to be registered by law or per NIH policy, as defined above.

• For Which Trials Must a Protocol be Uploaded to ClinicalTrials.gov?

  • Studies for which results are reported at ClinicalTrials.gov. Before uploading a protocol to ClinicalTrials.gov, contact CTRC, who will coordinate a review of the protocol for any information that must be redacted and will provide guidance on the legally required methods for redaction and preparation of the file for upload to ClinicalTrials.gov.

• Who is Responsible for Registration and Results Submission at ClinicalTrials.gov?

  Per the law and NIH policy, the entity responsible for registering and submitting results is the "Responsible Party,” defined by law at this link and NIH at this link. For UTHealth PI-initiated studies, the UTHealth PI is designated the "Responsible Party" and is responsible for registration and results submission. For industry-sponsored trials or multi-site trials, the industry sponsor or lead site is typically responsible for registration and results submission. Only one record should be created for a trial.

• What are the Due Dates for ClinicalTrials.gov Registration, Results Reporting, and Protocol Upload?

  To help you remember important due dates, keep the guidance document at this link handy.

  Registration: The law and NIH policy require registration no later than 21 days after enrollment of the first participant. ICMJE journals require registration at or before the time of first participant enrollment. Our recommendation is to register after IRB approval but before enrollment of the first participant.

  Results Reporting: Per the law and NIH policy, results must be reported no later than one year after the study's “Primary Completion Date,” which is defined as the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated." ICMJE does not require results reporting.

  Protocol Upload: Per the law and NIH policy, a protocol must be uploaded to ClinicalTrials.gov at the time of results entry, which is required no later than one year after the study's “Primary Completion Date,” defined as the "date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated."

• What are the External Penalties for Noncompliance with ClinicalTrials.gov Registration and Results Reporting Requirements?

  • Under the Final Rule and FDAAA Section 801, FDA has the ability to issue fines of at least $10,000 a day, per the FDA guidance at this link.
  • NIH funding may be suspended or withheld, for both individual studies and institutions as a whole, and past performance at ClinicalTrials.gov may affect future funding decisions.
  • Journals following the ICMJE recommendations may refuse to publish studies that were not registered before the time of first patient enrollment.
  • AllTrials FDAAA TrialsTracker (at this link) tracks and publicly posts studies that are out of compliance with the results reporting regulations.