University Policy
Title
University of North Carolina at Chapel Hill Policy on Managing Clinical Research Administrative Data
Introduction
Purpose
This Policy is meant to describe how the University of North Carolina at Chapel Hill (“UNC-Chapel Hill” or “University”) manages Research Administrative Data for certain types of Clinical Research studies.
Scope
This Policy applies to all University Units and Covered Individuals involved in the conduct of Clinical Research - unless covered by an Exception below - that requires individual participant informed consent.
This Policy also applies to all Clinical Research for which the University is responsible, regardless of the location of the Clinical Research or the source of financial support for the research. 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. As part of that effort, UNC-Chapel Hill has established a centralized Data Management System ("DMS"), as designated by the Office of the Vice Chancellor for Research, for researchers to use when conducting Clinical Research.
All University Units 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,
- ensure 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 about managing Clinical Research administrative data so long as those policies supplement and do not conflict with this Policy.
Record Keeping
University Units 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 a discrepancy 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).
- Registry studies that require no billing to subjects or sponsors.
- Any survey-only study determined as not human subjects research by the UNC-Chapel Hill Office of Human Research Ethics (OHRE).
- Human subjects research studies the OHRE 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) (exempt research).
- Studies in which UNC-Chapel Hill is the data coordinating center only.
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 as part of the management and operation supporting the conduct of Clinical Research. See the accompanying University Standard on Managing Clinical Research Administrative Data for specifics.
- 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
Primary Contact
Name: Christina Smith
Title: Director, Clinical Research Informatics
Unit: Office of the Vice Chancellor for Research
Email: ccsmi@unc.edu