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Clinical Trials Resource Center

ClinicalTrials.gov Support

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.

Contact CTRC at clinicaltrials@uth.tmc.edu for help with:

  • 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)

ClinicalTrials.gov FAQs

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 clinicaltrials@uth.tmc.edu, 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.

Related Links

• 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

ADDITIONAL RESOURCES

CLINICAL RESEARCH UNITS (CRU) | BERDREDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS | ANIMAL RESEARCH | ENVIRONMENTAL HEALTH & SAFETY | CORE LABORATORIES | SPONSORED PROJECTS TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH 

Center for Clinical and Translational Sciences

Clinical Trials Resource Center (CTRC)
7000 Fannin Street, Suite 795

Houston, Texas 77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu