Clinical Trials Registration and Results Reporting

HSPP QA Team

Why Should I Register and Submit Results?

Your study requires Registration and Results Reporting if any of the following common reasons apply:

  1. Required by Law For FDA Regulated: Applicable Clinical Trial (ACT) as described in FDAAA 801 and the Final Rule.
    • Meets FDA's FDAAA Regulation definition of Clinical Trial [View ACT Checklist] For Evaluating Whether your project is an Applicable Clinical Trial (ACT)]; Includes clinical studies with no external sources of funding, or "unfunded" studies.
  2. Sponsored by the National Institutes of Health (NIH)
  3. Intended for Publication in an International Committee of Medical Journal Editors (ICMJE) Member Journal
  4. Study renders claims for items and services from the Centers for Medicare and Medicaid Services (CMS) as a Clinical Trial
    • Study submits claims to CMS for items and services for Routine Costs in Clinical Trials as defined in the Medicare National Coverage Determination (NCD) Manual" (Chap 1, Part 4, Section 310.1, pg160)
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Clinical Trial Registration Resources

Requirements and responsibilities for clinical trials registration.

Need Help With Clinical Trials Registration and Results Reporting?

Contact the Rutgers ClinicalTrials.gov Protocol Registration System (PRS) Administrator

Rebecca Chen, Human Subjects Protection Senior Analyst

Department Phone: (973) 972-1149

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