ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world. The Research Integrity and Regulatory Affairs team provides guidance on clinicaltrials.gov accounts and maintenance of registered studies on
the Clinical Trial.gov PRS web used to register clinical studies.
Submit Studies to ClinicalTrials.gov PRS
The University of Texas Medical Branch at Galveston participates and sponsors the registration of clinical studies on ClinicalTrials.gov to comply, where applicable with Final Rule (42 CFR Part 11) regulations and to fulfill the obligations as a condition
for required publication of research study results set forth by The International Committee of Medical Journal Editors (ICMJE).
The ClinicalTrials.gov Protocol Registration and Results System (PRS) is a web-based data entry system used to register a clinical study and submit results information for a registered study.
UTMB has established one account on ClinicalTrials.gov for this academic institution. All investigators who are conducting clinical studies can become users of this ClinicalTrial.gov PRS account. To use the ClinicalTrials.gov PRS system, you must have
a username and password. If you don’t have one, please contact your department chair trusted requestor to send a Tivoli request.
Send Tivoli request to Tina Mack-Moshay at tlmackmo@utmb.edu to request an account in order to Login to ClinicalTrials.gov PRS.
Checklist for Evaluating Clinical Study
The ACT Checklist is intended to assist investigators or users of a clinical study who are registering on Clinical Trial.gov a tool to evaluate whether a Clinical trial or study is an Applicable Clinical Trial (ACT) under FDA Final Rule
under 42 CFR 11.22(b) initiated on or after January 18, 2017. Click on the box below to obtain access to the checklist.
Why Do I Need to Register my Clinical Trial and Submit Study Results to ClinicalTrials.gov?
The purpose of clinical trials is research to facilitate innovation and for discovering new ways of treatment so the studies must follow strict scientific standards, laws, and rules. These standards and laws protect research participants, patients and
help produce reliable study results. Refer to Department
Required by Law
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration
Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017. For more information on the Final Rule:
Required to comply with Office for Human Research Protections (OHRP)
The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research done or supported by HHS. The OHRP helps protect the rights, welfare, and well-being of research participants. It provides
guidance and oversight to the Sponsors and IRBs, develops educational programs and materials, and offers advice on research-related issues. Visit the OHRP Web site for Common Rule.
Required for Publication
The International Committee of Medical Journal Editors (ICMJE) requires trial registration and study as a condition of the publication of research results generated by a clinical trial. See the ICMJE section of the Support Materials page or visit the
ICMJE Web site.