ClinicalTrials.gov

Title: ClinicalTrials.gov
Policy Owner: Research Compliance Services, Office of the Vice President for Research
Applies to: Employees, Faculty, Students, Other
Campus Applicability:  All Campuses
Effective Date: May 25, 2018
For More Information, Contact Office of the Vice President for Research
Contact Information: (860) 486-3001
Official Website: http://research.uchc.edu/

 

REASON FOR POLICY

The purpose of this policy is to ensure investigators at the University comply with the requirements for registering and reporting results of clinical trials at ClinicalTrials.gov.

The University is committed to the mission of public availability of clinical trial information and to complying with the related requirements of the Food and Drug Administration (FDA), National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services (CMS) and other federal agencies and departments for using ClinicalTrials.gov.  Investigators for certain clinical trials are required to register and report results at ClinicalTrials.gov for certain clinical trials, including those involving the FDA, NIH, and CMS.  The International Committee of Medical Journal Editors (ICMJE) also imposes a similar requirement as a condition for seeking publication in participating journals.

APPLIES TO

All University faculty, employees, students, postdoctoral fellows, residents and other trainees, and agents who supervise or conduct clinical trials needing to be registered at ClinicalTrials.gov.

POLICY STATEMENT

It is the responsibility of the Principal Investigator (or other equivalent individual) supervising or conducting a clinical trial that must be registered at ClinicalTrials.gov to ensure that the registration, results reporting, related consent form and other applicable requirements are met with the required timeframes.  Any failure to fulfill these requirements may result in limitations on publications or grant submissions or other sanctions.

The University’s Protocol Registration and Results System (PRS) Administrator within Research Compliance Services is available to provide assistance in navigating the PRS system, administering requests by ClinicalTrials.gov, and with compliance questions related to these requirements.

ENFORCEMENT

Violations of this policy may result in appropriate disciplinary measures in accordance with University By-Laws, General Rules of Conduct for All University Employees, applicable collective bargaining agreements, the University of Connecticut Student Code, and other applicable University Policies.

Authority

42 CFR part 11 (FDA)

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (NIH)

Medicare Clinical Trial Policies (CMS)

Clinical Trials (ICMJE)

Policy History:

Adopted: 5/25/2018 (Approved by President’s Cabinet)