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Clinical Trials

Clinical trials are research studies performed in people to evaluate medical, surgical, or behavioral interventions. They are the primary way researchers determine the effectiveness and safety of new treatments.

 

CLINICAL TRIALS AT UTHSC

 

Clinical Trials Groups

Clinical Trials Industry Advisory Committee

Regulatory Support

Participate in a study

Tools and Resources


ClinicalTrials.gov

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

Protocol registration is required make study information publicly available to facilitate enrollment in clinical trials, allow tracking of study progress, disseminate study findings, and ensure access to peer-reviewed journals for publication of research outcomes. Protocol registration is required by:

  • Food and Drug Administration Amendments Act 2007 (FDAAA)
  • National Institutes of Health (NIH)
  • International Committee of Medical Journal Editors (ICMJE)
  • Center for Medicare and Medicaid (CMS)

International Committee of Medical Journal Editors (ICMJE) requires protocol registration of interventional clinical studies to include studies of any intervention type, phase, or geographic location BEFORE enrollment of first subject.

ClinicalTrials.gov Protocol Registration User’s Guide

Protocol Registration Information

UTHSC procedures for ClinicalTrials.gov registration 

If you need to register a study in ClinicalTrials.gov, send the following information to ocrdev@uthsc.edu

  • Name and title with degrees
  • UT NetID

You will receive instructions by email from the UTHSC ClinicalTrials.gov administrator for registering your study.

 

Mandatory HSP/CGP Training

UTHSC clinical researchers are required to complete training in human subject protections and good clinical practices. Documented coursework in these areas are mandated by the DHHS Office of Human Research Protections, Food and Drug Administration (FDA) and the National Institutes of Health (NIH). UTHSC uses CITI (Collaborative Institutional Training Initiative) for clinical researcher training.

CITI Info & Links

 

Jan 31, 2024