Huntsman Cancer Institute

Policies and Procedures

Institutional Data Management
General Policy Number: 6.18

I. Description

Defines Huntsman Cancer Institute (HCI) policies for staff, faculty, and volunteers concerning the use of institutional resources for building and maintaining research database systems. These database systems are critical for effective, HIPAA compliant, and integrated tracking of research data. They are critical to one of HCI's most valued assets, its integrated, multilevel data environment.

II. Applies To

• HCI research and cancer hospital employees
• Faculty
• Volunteers

III. Definitions

IV. Policy(ies)

A. General

1. Users will refer to University of Utah (U of U) Policy 4-001 regarding principles of management, security, and access to maintain the value and guarantee effective use of institutional data and information.

2. Users will refer to U of U Policy 4-004 regarding compliance with information security policies.

3. HCI makes research database systems available for the use of HCI and U of U faculty, staff, and others. U of U Information Resources Policy 4-002 states these resources are intended for educational purposes and the legitimate business of the University in a manner consistent with the public trust. Appropriate use of the resources includes instruction, independent study, continuing education, authorized research, independent research, and the official work of the offices, departments, and recognized student and campus organizations of the University.

4. Inappropriate uses include interfering with the work of others, wasting resources, using resources for personal use, and any activities that include the violation of state or federal laws and University policies and procedures.

5. HCI provides research database resources that faculty, staff, students, and others need for effective, transparent, integrated, and state-of-the-art tracking of important research data. Using other methods to capture valuable research data increases vulnerability to misuse, loss, and lack of integration. HCI's Senior Leadership and Executive Director expect that all related research information will be housed and managed in institutionally supported database systems, including these:

   • OnCore Clinical Trials Management
   • itBioPath Specimen Management
   • LabVantage Laboratory Information Management
   • Cancer Clinical Research (CCR)
   • Genomic Experimental Repository (GNomEx)
   • Research Subject Registry (RSR)
   • REDCap
   • Utah Population Database (UPDB)

6. Use of institutionally approved research data systems affords many benefits to HCI leadership:

   • Stewardship of University information assets
   • Authenticated access in compliance with University, HIPAA, IRB, CCIC, and RGE standards
   • Automated tracking (audits) of patient data usage, as required for University HITECH compliance
   • Data housing on secure servers with up-to-date surveillance for malicious attacks
   • Timely and secure backups with provisions for recovery of deleted data
   • Efficient and effective management of data entry staff resources for all cancer oncology domains, minimizing or eliminating redundant data entry labor
   • Facilitation and support of data integration projects, including Electronic Data Warehouse, UPDB, U of U Health Sciences Center Tumor Registry, and other resources
   • Multi-user support for day-to-day data collection operations, including secured remote access and troubleshooting support
   • Prevention of duplicate Shared Resources software engineering efforts to upload, normalize, and assure the quality of data

B. Individual Responsibilities

1. Individual use of institutionally supported databases must comply with state and federal laws and U of U policies and regulations.

C. Enforcement

1. HCI may monitor use of non-institutional research database resources. Users may be asked to provide documentation regarding appropriate use of such databases.

2. Violation of this policy may result in the withdrawal of access and potential disciplinary or academic sanctions, consistent with U of U policies and regulations. Users will also be asked to reimburse HCI for the use of resources.

Printable PDF file: HCI-Data-Policy-6.18-InstitutionalDataManagement.pdf