Protocols that meet any of the following criteria must be entered into OnCore:
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.
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)
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.
The use of the OnCore system is available at no cost to research teams.
SMPH REDCap is not required for any type of clinical research study, but is recommended in lieu of a typical spreadsheet, database software or data management application to manage your research study data due to the additional levels of security, audit trails, reporting and exporting functionality it offers.