Regulatory & Ethics Tools

CLINICALTRIALS.GOV PAGE

Federal law and journal publication standards require that investigators register their clinical studies in a publicly accessible database. The ClinicalTrials.gov database is a tool to support compliance with these rules and regulations.

The FDA Amendments Act of 2007 (FDAAA) assigns this mandate to a "Responsible Party" and defines a set of "Applicable Clinical Trials" that must be registered. FDAAA stipulates that many prospective clinical trials involving drugs, biological products, and devices must be registered and a subset of these studies also must post results.

The International Committee of Medical Journal Editors (ICMJE) policy (adopted by over 1,000 journals, including JAMA and NEJM) is broader in scope than FDAAA. ICMJE policy requires study registration. The policy applies to research that prospectively assigns human subjects to intervention or comparison groups in order to look at the cause-and-effect relationship between an intervention and a heath outcome.

LA CaTS INSTITUTIONS – PRS ADMINISTRATORS

Institution

ClinicalTrials.gov PRS Administrator

Children’s Hospital

Emily Moran, Director, Research Operations

LSU A&M

Dennis Landin, PhD, IRB Chair

LSU Health – New Orleans

Kadie Rome, IRB Coordinator

LSU Health – Shreveport

Ron Denny, Assistant Director of Compliance

Ochsner Health System

Maria T.W. Zeringue, Senior Project Coordinator

Pennington Biomedical

Lori Steib, Director, Library &  Information Center

Tulane University

Brian Weimer, Director, University Research Compliance Office

Veterans Health Administration

Richard Mirabelli, MPH, Administrative Officer For Research

Xavier University – New Orleans

Deborah Marshall, PhD, Associate Vice President for Research and Sponsored Project

University Medical Center – New Orleans

 

This work was conducted with support from Harvard Catalyst l The Harvard Clinical and Translational Science Center (National Center for Advancing Translational Sciences, National Institutes of Health Award UL 1TROO2541) and financial contributions from Harvard University and its affiliated academic healthcare centers. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Catalyst, Harvard University and its affiliated academic healthcare centers, or the National Institutes of Health.

Harvard Catalyst Clinical Trial Registration and Results Reporting

Please note by clicking on the links below, you will be leaving the LA CaTS website and going to Harvard Catalyst website.

RESOURCES

HELPFUL LINKS AND ADDITIONAL INFORMATION