Managing Clinical Research Administrative Data Policy

University Policy

Title

University of North Carolina at Chapel Hill Policy on Managing Clinical Research Administrative Data

Introduction

Purpose

This Policy describes how the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”) manages Research Administrative Data for specific Clinical Research studies.  

Scope

This Policy applies to all University Units and Covered Individuals involved in Clinical Research that requires written informed consent from participants unless an Exception is noted below. 

This Policy also covers all Clinical Research for which the University is responsible, regardless of the location or funding source.  See exclusions below. 

Policy

Policy Statement

The University is committed to improving the health and well-being of all North Carolinians and people across the globe. To support this effort, UNC-Chapel Hill has implemented a centralized Data Management System ("DMS"), as designated by the Office of the Vice Chancellor for Research (OVCR), for researchers conducting Clinical Research. 

All University Units and Covered Individuals subject to this Policy are required to use the DMS to manage Clinical Research Administrative Data. Any Covered Individual who does not use the DMS as described in this Policy and the accompanying University Standard on Managing Clinical Research Administrative Data may be subject to disciplinary action. 

The DMS is intended to allow the University to: 

  • Efficiently and accurately track funding sources and expenses,  
  • Support Clinical Research operations and collaboration, 
  • Promote legal and regulatory compliance, and  
  • Improve awareness of the University’s Clinical Research portfolio and impact through reporting and data analysis. 

University Units may implement and maintain Unit-specific policies for managing Clinical Research Administrative Data, provided these policies supplement and do not conflict with this Policy. 

Record Keeping

University Units and Covered Individuals must: 

  • Enter information into the DMS that is accurate to the best of their knowledge, and 
  • Complete all required data fields for their research as described in the accompanying University Standard on Managing Clinical Research Administrative Data. 

This will provide current, reliable information and reduce redundancies and errors in how the University manages Clinical Research administrative data. In the event of any discrepancies between Research Administrative Data in the DMS and Research Administrative Data in any other system, the data in the DMS is the controlling version. 

Exceptions

The following studies are excluded from complying with this policy: 

  • Specimens collected for broad use and not solely for a specific study (e.g., Biobanks) with no billing to subjects or sponsors. 
  • Retrospective or prospective chart reviews with no clinical procedures (e.g. sample collection), surveys, or billing to subjects or sponsors. 
  • Any survey-, focus group-, and/or interview-only study with no clinical procedures (e.g. sample collection) or billing to subjects or sponsors.
  • Human subjects research studies the Office of Human Research Ethics has determined are exempt from 45 CFR 46.116 (waiver of consent) or 45 CFR 46.117 (waiver of written documentation of consent). 
  • Studies falling under 45 CFR 46.104(d)(4) (Exemption 4).
  • Studies in which UNC-Chapel Hill is the data coordinating center only. 
  • Other exceptions may be granted by OVCR.

Definitions

  • Clinical Research: For the purpose this policy, the National Institutes of Health (NIH) definition of Clinical Research applies: “Research with human subjects that is: 
    • Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. It includes:  
      • mechanisms of human disease,  
      • therapeutic interventions,  
      • clinical trials, or  
      • development of new technologies. 
    • Epidemiological and behavioral studies. 
    • Outcomes research and health services research"
  • Research Administrative Data: Documents and information created, collected, or maintained to support the management and operation of Clinical Research. See the accompanying University Standard on Managing Clinical Research Administrative Data.  
  • Data management system (DMS): A software solution for the collection, organization, protection, and storage of an organization’s Clinical Research Administrative Data.  
  • Covered Individuals: Individuals engaged in Clinical Research. This includes faculty, staff (SHRA and EHRA non-faculty), students, guest researchers (e.g., unpaid volunteers, interns, and visiting scholars), collaborators, and consultants.   
  • University Units: Any Department, Division, or Center/Institute of the University of North Carolina at Chapel Hill.  

Related Requirements

External Regulations

University Policies, Standards, and Procedures

Contact Information

Policy Contact

Name: Christina Smith
Title: Director, Clinical Research Informatics
Unit: Office of the Vice Chancellor for Research
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