Clinical Trials Registration & Results Reporting
What to Register
Federal regulations and policy require public registration of clinical trials and results reporting:
- FDA Defined Applicable Clinical Trials (ATC) (42 CFR Part 11)
Applicable clinical trials, regardless of funding source, must be registered. ACTs generally include:
- Controlled clinical trials of FDA-regulated drugs or biologics (Phases II – IV)
- Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies)
- Research studies testing a clinical hypothesis about health outcomes, including:
- research whose primary purpose is to affect clinical practice
- nutritional studies
- social behavioral research focusing on health outcomes
- National Institutes of Health (NIH) Funded Research
NIH funded clinical trials require registration per NIH policy. If the answer is “yes” to all four of the following questions, then the research study meets the NIH definition of a clinical trial and must be registered.
- Does the study involve human participants?
- Are the participants prospectively assigned to an intervention (placebo or control)?
- Is the study designed to evaluate the effect of the intervention on the participants?
- Is the effect being evaluated a health-related biomedical or behavioral outcome?
Use the NIH Decision Tool to help determine if your study meets the NIH definition of clinical trial.
- International Committee of Medical Journal Editor (ICMJE) Requirements
Registration is required prior to enrollment of the first research participant in order to be eligible to publish in a journal that follows the ICJME guidelines. Studies requiring registration include:
- All studies meeting the NIH definition of clinical trial
- Phase 1 drug studies
- Device feasibility studies
- Center for Medicare and Medicaid Services (CMS) Requirements
It is important to note that the CMS requires a National Clinical Trial (NCT) number for coverage of routine costs of qualifying clinical trials. An NCT number is provided by successful registration at ClinicalTrials.gov.
Where to Register
ClinicalTrials.gov is the primary database for registering and reporting clinical trial results. Other public databases exist as an option. Before selecting a database other than ClinicalTrials.gov, review the list of acceptable databases for ICJME journals.
When to Register
ICJME recommends registration prior to enrollment of the first research participant.
Federal regulations and NIH policy require new qualifying trials/studies to register no later than 21 days after the first participant is consented.
Who should Register
The individual responsible for registering a clinical trial is considered the “Responsible Party.” At the University of Texas at Austin, any researcher in the role of Principal Investigator of investigator-initiated research is designated the Responsible Party with some exceptions:
- If there is an IND or IDE held by someone other than the PI, the IND or IDE holder is the Responsible Party
- Multi-site studies typically designate the lead institution as the Responsible Party.
The Responsible Party is required to ensure that study registration, required record updates, and results reporting are completed in a timely manner, according to HHS regulations and federal policy.
Frequently Asked Questions
Who can help me register my study?
Office of Research Support & Compliance Quality Program
Dell Medical School
Research Operations Team
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.”
The ClinicalTrials.gov information posted to the ORSC website is adapted from the University of Michigan, ClinicalTrials.gov resources at Spectrum, the Stanford Center for Clinical and Translational Research and Education, supplemented by resources from the University of Texas at Houston Science Center and the ClincialTrials.gov website.