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ClinicalTrials.gov

ClinicalTrials.gov is a web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH), and registration is required by law for certain clinical trials of drugs, medical devices, and biological products. Registration is also required in many cases for journal publication.

Why?

The University of Houston requires registration of all applicable clinical trials in the ClinicalTrials.gov registry, not only to maintain compliance with federal regulations, but also as an educational tool for human subject volunteers. Registration provides a mechanism to ensure continuity in the research enterprise, which supports research integrity through the dissemination of research results, whether positive or negative.

What?

Registration is required for trials that meet the FDAAA 801 definition of an "applicable clinical trial" and were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. Trials that were ongoing as of September 27, 2007, and reached the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007, are excluded. "Applicable Clinical Trials" include the following:

  • Trials of drugs and biologics. Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation
  • Trials of devices. 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric post market surveillance required by FDA
  • "Applicable clinical trials" generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:
  • The trial has one or more sites in the United States
  • The trial is conducted under an FDA investigational new drug application or investigational device exemption
  • The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research

Please review the following page to determine if you are required to register at ClinicalTrials.gov.

Who?

FDA regulations require the responsible party to register applicable clinical trials. The responsible party is the sponsor of the clinical trial, meaning the person who initiates a clinical investigation.

  • For investigator-initiated trials, the lead Principal Investigator is responsible for initiating, conducting, and coordinating the overall clinical trial for registration
  • For sponsor-initiated trials, the sponsor is responsible for registration
  • For trials sponsored or funded entirely or in part by the NIH, the grantee is responsible for registration
  • For trials associated with Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications with the FDA, the IND/IDE holder is responsible for registration

**If it is unclear who is responsible for registering an applicable clinical trial, investigators should consult with the sponsor, funding agency, and/or other study investigators to define who the responsible party will be.**

When?

The Food and Drug Administration Amendments Act (FDAAA) requires registration:

  • 21 days after enrollment of the first participant and results reported no later than one year after the primary completion date whether the study is completed or is terminated.

International Committee of Medical Journal Editors (ICMJE) requires registration:

  • Prior to enrollment of the first study participant

**The responsible party is accountable for ensuring that their protocol records are updated for all registered clinical trials at least every six months or earlier if there is a change in the status of the trial.

How?

The University of Houston has an organizational account with ClinicalTrials.gov. Registration is completed through the menu-driven Protocol Registration System (PRS) by entering the organization name (enter UHouston) and your user name and password.

Once all of the information has been entered in the PRS record and marked as complete, an automated email will be sent to the university administrator, who is housed in the DOR Office of Research Policies, Committee, and Compliance, for review. Upon completion of the review, the administrator will approve and release the record to ClinicalTrials.gov, where the PRS team will review the record for quality control purposes prior to posting on the ClinicalTrials.gov website.

If you are unsure of your username and password, or need assistance in registering or establishing an account contact Alicia Vargas.