OnCore: Protocol Entry Requirements

Protocols that meet any of the following criteria must be entered into OnCore:

  1. Protocols that use University of Wisconsin Hospitals and Clinics (UWHC) (including the Clinical Research Unit - CRU) or University of Wisconsin Medical Foundation (UWMF)  services, facilities or staff in which the services result in a UWHC or UWMF charge on the patient’s account.
  2. Therapeutic intervention protocols being conducted within the auspices of UW-Madison or the UW-Madison Affiliated Covered Entity (ACE) that involve the use of:
    • Drugs (including over the counter medications, vitamins, herbals, and supplements)
    • Biologics (including vaccines and stem cells)
    • Devices
    • Radiation therapy or medical imaging
  3. Protocols that use an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)
  4. All cancer-related studies conducted at the University of Wisconsin must be reviewed by UW-CCC Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation.

Other Data Capture Resources

Study teams which would like to capture study data can also use REDCap:  REDCap: Overview .




Keywords:faq protocols enter OnCore Carbone Comprehensive Cancer Center UWCCC required requirement mandatory requirements CRU investigational   Doc ID:12775
Owner:Sheri A.Group:SMPH Research Informatics
Created:2009-11-30 19:00 CDTUpdated:2022-04-01 12:11 CDT
Sites:ICTR Test, Institute for Clinical and Translational Research, SMPH Research Informatics
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