Clinical Trials Registration and Results Reporting

Responsible Party (RP): Rutgers University defines “Responsible Party” as the Principal Investigator who is responsible for conducting a clinical trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this policy.

A Principal Investigator is the individual who assumes full responsibility for a research project, including the supervision of any co-investigators, research assistants, house staff and students and assuring all study personnel adhere to federal regulations, state and local laws, institutional policies, IRB policies and procedures regarding the safety and protection of human subjects, and good clinical practice guidelines (GCP).

Responsibilities

1. Register

2. Results Reporting

3. Updates

1. When To Register Your Study
2. When To Submit Clinical Trial Updates
3. When To Post My IRB Approved Consent Form
4. When To Submit Results

***(3) Sections 46.102(b) and 46.116(h) of the 2018 Revised Common Rule requires clinical trials post one IRB-approved version of a consent form that has been used to enroll participants on a public federal website designated for posting such consent forms.
 

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)

View Instructions for ClinicalTrials.gov Protocol Registration and Results Reporting Guide (PDF)

A data sharing statement indicates the following:

• whether individual de-identified participant data (including data dictionaries) will be shared;
• what data in particular will be shared; whether additional, related documents will be available (e.g. study protocol, statistical analysis plan, etc.);
• when the data will become available and for how long;
• by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism)

Adding a Data Sharing Statement to Clinicaltrials.gov (PDF)

As Required By:

• International Committee of Medical Journal Editors (ICMJE): ICMJE’s Data Sharing Statement Policy
• NIH Data Sharing Policy and Implementation Guidance: (Learn More) (2023 NIH Data Management & Sharing Policy) (Additional NIH Resources)
  • For NIH Data Sharing Policy assistance contact Rutgers Office of Research and Sponsored Programs

For further training and information on registering a trial or submitting results, please see the following webinars created by the ClinicalTrials.gov team:

Overview of ClinicalTrials.gov and Related Policies

1. Understanding the Definition of a Clinical Trial and What That Means for You (Audio 13min)
2. Overview of New NIH Policies on Human Subjects Research and Clinical Trials (Video 14min)
3. Overview of ClinicalTrials.gov (Video 28min)
4. Key FDAAA Issues (Video 9min)

Submitting Results Data in the ClinicalTrials.gov Protocol Registration and Results System (PRS)

1. Results: Participant Flow Module (Video 17min)
2. Results: Baseline Characteristics Module (Video 12min)
3. Results: Outcome Measures and Statistical Analyses Module (Video 13min)
4. Results: Adverse Events Module (Video 12min)

Rutgers

•  Clinical Trials Registration and Results Reporting Policy [Rutgers University] (PDF)

Federal

• FDAAA 801 Requirements: Food and Drug Administration Amendments Act
• Notice From The Centers for Medicare & Medicaid Services: Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims (PDF)
• Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Sections 200 – 310.1) (PDF)
• CMS Medicare Clinical Trial Policies
• NIH Elaboration Document of "Responsible Party" and "Applicable Clinical Trial" 2009 (PDF)
• Final Rule: Clinical Trials Registration and Results Information Submission 2016
• Final Rule Information: Clinical Trials Registration and Results Information Submission (42 CFR Part 11) (clinicaltrials.gov)

Other

• International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Requirements

ClinicalTrials.gov:

• FAQ From Clinicaltrials.gov
• General ClinicalTrials.gov Information  
• Summary Table of FDAAA 801 and NIH Policy on Clinical Trials Registration and Reporting
• ClinicalTrials.gov Registration and Results Reporting Decision Tree

FDAAA

• FAQ: FDAAA - Further Resources for NIH Grantees

Tips For ClinicalTrials.gov Users 

• How To Avoid Common Problems When Using Clinicaltrials.Gov In Research: 10 Issues To Consider (bmj.com)