Clinical Trials Registration and Results Reporting

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Announcement

  • PRS Guided Tutorials For Registration Content Now Available: PRS Guided Tutorials now include registration content providing step-by step instructions for submitting registration and results information in the ClinicalTrials.gov Protocol Registration and Results System (PRS).
  • Answers to Questions from Responsible Parties on Submitting Information to ClinicalTrials.gov Related to Coronavirus (COVID-19) Now Available: Questions have been addressed in Responses to Top Questions from Responsible Parties Related to Coronavirus (COVID-19) [PDF]. COVID-19 is an emerging, rapidly evolving situation. These responses will be updated as needed. See the Support Materials page to access the document.

  • Train-the-Trainer Workshop Postponed: The Results Database Train-the-Trainer Workshop scheduled for May 18-19, 2020 is cancelled and will be rescheduled as a later date. Updates will be provided when available.
  • Do I need to register modifications with ClinicalTrials.gov? Some studies registered at the federal site ClinicalTrials.gov are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms. The ClinicalTrials.gov information for the study should be updated to include these new procedures, if they are done for research purposes. If they are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. The federal requirement about modifications is that any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification. (updated 3.9.2020)
  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic-March 2020 (PDF)

 

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)

Need Help? Contact Us

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.