Office of the Vice Chancellor for Research

- Research Resources Overview
- - Shared Cores
    Our cores and shared resources offer a wide range of services to meet your research goals.
  - Shared Equipment
    Shared equipment is available to University of Nebraska and external researchers.
- - Study Intake
    Take the first step in conducting clinical research on campus by completing the study intake process.
  - Standard Operating Procedures
    Review the standard operating procedures of our clinical research program.
  - Education
    Learn more about training and education opportunities available for the campus clinical research community.
  - Recruitment
    Discover resources, guidelines and support to make the research recruitment process streamlined.
- - Software
    Find the software and applications that can take your research to the next level.
  - Data Management
    Explore data management plan creation and storage options to keep research data safe and secure.
  - IT Resources
    Access key tools, workshops and seminars with IT resources available.
  - Network Connectivity
    Learn about lab network connectivity available across campus.
- - Buildings
    Research buildings offer a wide-range of lab spaces and facilities to meet researchers' needs.
  - Space Policy
    Research space is assigned based on a merit-based system.
- Programs & Centers Overview
- Approved Centers
  Board of Regents Centers enhance faculty research and academic efforts.
- Major Programs
  Major research programs drive innovation in critical areas of biomedical science.
- Compliance Overview
- Institutional Review Board
  The IRB reviews human subjects research projects and ensures the protection of participants.
- Institutional Biosafety Committee
  The IBC ensures the health and safety of all personnel working with biohazardous agents.
- Institutional Animal Care & Use Committee
  The IACUC reviews research and provides guidance to maintain the highest standards of animal welfare.
- Investigational Device Review Committee
  The IDRC reviews investigational devices and approved devices provided by sponsors for use in clinical research studies.
- Funding Overview
- Sponsored Programs Administration
  Our office manages the full lifecycle of sponsored research projects.
- Funding Opportunities
  Find internal and external research funding opportunities.
- Grant Editing
  Grant review and editing resources are available to UNMC researchers.
- UneHealth
  UNeHealth supports clinical research projects throughout the life of industry-funded contracts.
- Innovation Overview
- Tech Transfer
  Our technology commercialization ecosystem helps researchers transform scientific discoveries into real-world solutions.
- Economic Development
  Through collaborations with strategic partners, we create pathways for innovation to drive economic growth.

— Office of the Vice Chancellor for Research — Research Resources — IT & Research Data — Software & Applications — REDCap — Federal Requirements

Federal Requirements

Title 21 Code of Federal Regulations Part 11

21 CFR part 11 is a federal requirement to assure the agency that electronic signatures are the legally binding equivalent of a person’s handwritten signature.

Does my research protocol need a part 11 compliant computer system?

Does your protocol fall under the purview of the FDA?
Is your protocol conducted under an approved IND?
Is your protocol conducted under an approved IDE?
Does your sponsor, grant (NIH), or other agency, specify that your computer system must
comply with 21 CFR part 11?

If you answered yes to any of the questions, then you need to use a 21 CFR part 11 compliant system.

What computer systems at UNMC and Nebraska Medicine are 21 CFR part 11 compliant?

One Chart (Epic) the electronic medical record for Nebraska Medicine
Forte Electronic Data Capture