The Clinical Trials Resource Center (CTRC) supports UTHealth study teams in complying with the regulations and policies for registration and results reporting at ClinicalTrials.gov.
UTHealth's ClinicalTrials.gov Policy and Procedures document is at this link.
- Determining whether registration and/or results submission are required, and determining which party is responsible
- ClinicalTrials.gov account setup
- Initial registration
- Record updates (guidance document at this link)
- Results reporting and protocol upload
- Informed consent form (ICF) upload per the Revised Common Rule (guidance document at this link)
- Determining due dates for registration, updates, results entry, protocol upload, and ICF upload (guidance document at this link)
- Outcome measure guidance (guidance document at this link)
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.
Informed Consent Upload per the Revised Common Rule
If you receive federal funding for a clinical trial, please review the brief guidance document at this link, which discusses the requirements for informed consent form (ICF) upload per the Revised Common Rule.
Section 45 CFR 46.116(h) of the revised Common Rule states that for clinical trials conducted or supported by a Federal department or agency, one IRB-approved informed consent form (ICF) that was used to enroll subjects must be posted by the awardee on a publicly available Federal Web site. This requirement applies to all federally-funded clinical trials that were initially approved by an IRB on or after January 21, 2019. For the purposes of determining whether a study approved with conditions is subject to the revised Common Rule, the date that the IRB voted to conditionally approve the study is the date that should be used (rather than the date that all conditions were met). The ICF must be posted after the clinical trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol. The UTHealth PI is responsible for ensuring that the ICF is uploaded on time. For UTHealth PI-initiated clinical trials, investigators will post ICFs to ClinicalTrials.gov. Redactions of, for instance, confidential commercial information are permitted—before posting any ICF to ClinicalTrials.gov, contact the UTHealth PRS Administrator at firstname.lastname@example.org, who will coordinate a review of the ICF to identify any information that should be redacted, as well as provide guidance on the legally required methods for redaction and preparation of the file for upload.
• U.S. Public Law 110-85
• FDA Amendments Act of 2007 (FDAAA)
• PRS and U.S. Public Law 110-85
• NIH Guidance on Law
• NIH FAQs on clinical trial registration
• ICMJE FAQs
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