Clinical Trials Registration and Results Reporting

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Overview

This website is intended to help Rutgers Investigators understand the requirements and responsibilities for clinical trials registration.

Creating An Account and Registering Your Protocol On ClinicalTrials.gov

ClinicalTrials.gov is a public database developed by the National Library of Medicine (NLM) that offers up-to-date information for locating federally and privately supported clinical trials for a wide range of diseases and conditions. Information available on ClinicalTrials.gov includes registration and results reporting information. ClinicalTrials.gov background information can be found on the ClinicalTrials.gov.

Instructions

  1. Create an ClinicalTrials.gov Account: View Instructions [PDF]
  2. Register Your Study (Enter the PRS Website)

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Definition of Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. (NIH.gov)

Study Requirements For Registration And Results Reporting

Registration And Results Reporting Of A Clinical Trial Is REQUIRED If Your Study Meets One or More of the Following Conditions:

  1. FDA Regulated Clinical Trial.
    • Includes Clinical studies with no external sources of funding ("unfunded" studies). View ACT Checklist For Evaluating Whether a Clinical Trial or Study Is An Applicable Clinical Trial (ACT).
  2. Funded (fully or partially) by National Institutes of Health. View NIH Definition of Clinical Trial Case Studies
  3. Plan to publish in a International Committee of Medical Journal Editors (ICMJE) Member Journal.
    • The ICMJE clinical trial registration policy requires public, prospective registration in an acceptable public registry or in the World Health Organization (WHO) International Clinical Trials Portal. However, by the conditions set forth by FDAAA 801, registration of a clinical trial on ClinicalTrials.gov requires the posting of summary results data. It is important to understand that ICMJE requires Principle Investigators to adhere to the registration guidelines of the chosen registry.
  4. Qualifying Clinical Trial which will render claims for items and services from the Centers for Medicare and Medicaid Services (CMS)
    • The National Clinical Trial (NCT) number must be included on claims for items and services provided in clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual," Section 310.1.