University Standard
Title
University of North Carolina at Chapel Hill Standard on Managing Clinical Research Administrative Data
Introduction
Purpose
This Standard is meant to provide the minimum expectations for users of the University of North Carolina at Chapel Hill’s ("UNC-Chapel Hill" or "University") Data Management System ("DMS") for Clinical Research Administrative Data. This Standard is intended to further the University’s goals of providing DMS users with efficient and accurate administrative data and to promote legal and regulatory compliance.
Scope
This Standard applies to all University Units and Covered Individuals involved in the conduct of Clinical Research that requires individual participant informed consent.
This Standard 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.
This Standard does not include Research Administrative Data housed in other University systems:
- The Institutional Review Board (IRB) system of record is the canonical source for the IRB-approved informed consent form (ICF).
- RAMSeS or/and ALICE is/are the canonical source(s) for fully executed Clinical Trial Agreements (CTA) and amendments.
- PeopleSoft is the canonical source for payments and expenditures.
Standard
The DMS is the University’s authoritative source for certain Clinical Research administrative data, including subject accrual data.
Individual Units may require entry of more information into the DMS or earlier timelines than outlined in this Standard, but Units may not require less information or extend timelines.
All studies that meet the requirements as outlined in the University’s Policy on Managing Clinical Research Administrative Data must include the following information in the DMS:
- Protocol Record. The minimum footprint of required protocol information, including IRB status information (regardless of IRB of record), must be entered in the DMS. Study teams must create the Protocol Record no later than five (5) business days following IRB approval. Protocol status must be updated within five (5) business days of a change. The DMS must also include electronic copies of the following protocol supporting documentation:
- Current approved protocol (or equivalent if no protocol exists),
- Administrative letters,
- Initial IRB approval letters and subsequent renewal approvals,
- Investigator brochure (if applicable),
- Lab manual (if applicable), and
- Pharmacy manual (if applicable).
- Registration of the participants and maintenance of up-to-date participant information. Electronic copies of all signed consent/assent documents must be uploaded to the subject record in the DMS.
Additionally, any study covered by the University’s Policy on Managing Clinical Research Administrative Data:
- Involving a UNC-Chapel Hill or UNC-Chapel Hill employee-held Investigational New Drug application (IND), Investigational Device Exemption (IDE), or Non-Significant Risk (NSR) medical device must record the drug or device in the DMS.
- Utilizing Investigational Drug Services (IDS) must ensure supporting documentation is available and up to date in the DMS.
- Involving sponsor invoicing (or "shadow" invoicing, in situations in which the sponsor sends payment based on data entry in the sponsor's system) must have financial information in DMS.
- Involving subject-related study visits, regardless of Epic billing or sponsor invoicing status, must have a subject calendar in the DMS.
Study teams must log subject-related study activities into the DMS within two (2) business days of occurrence.
Study teams must log study-defined milestones into the DMS within ten (10) business days of completion.
All DMS users must complete role-appropriate training before permission to enter data in the system is approved.
Exceptions
Please refer to the University’s Policy on Managing Clinical Research Administrative Data for all relevant exceptions.
Definitions
See definitions in the University’s Policy on Managing Clinical Research Administrative Data.
Protocol Record: Information related to the management of a clinical research study, including, but not limited to:
- title,
- department,
- protocol type,
- phase,
- accrual goals,
- completion date,
- protocol status,
- staff,
- sponsors,
- IRB review status,
- IND/IDE data, and
- associated documents.
Related Requirements
University Policies, Standards, and Procedures
Contact Information
Name: Christina Smith
Title: Director, Clinical Research Informatics
Unit: Office of the Vice Chancellor for Research
Email: ccsmi@unc.edu