Investigator Responsibilities

Printer-friendly version

Overview

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
 
Instructions

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

 

Data Sharing Statements

A data sharing statement indicates the following: whether individual deidentified 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).

 

International Committee of Medical Journal Editors (ICMJE) Requirements