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
  • Protocols that use an investigator-held Investigational New Drug (IND) or Investigational Device Exemption (IDE)
  • 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 18:00 CSTUpdated:2022-04-01 11:11 CST
    Sites:ICTR Test, Institute for Clinical and Translational Research, SMPH Research Informatics
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