OnCore: Protocol Entry Requirements

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

  1. All cancer-related studies conducted at the University of Wisconsin must be reviewed by UWCCC Protocol Review and Monitoring Committee (PRMC) scientific review committee prior to study activation. https://kb.wisc.edu/smph/informatics/internal/44463
  2. Protocols that require any UW Hospitals and Clinics (UWHC/UW Health) procedures and/or use any resources that would result in a charge on a patient’s record (e.g. labs, Clinical Research Unit, Pharmaceutical Research Center, WIMR Imaging)  
  3. Protocols that meet the definition of either Clinical Research or Clinical Trial, as outlined in UW Health policy 4.24

    Clinical Research, as defined by the National Institutes of Health (NIH), is research in which people, or data or samples of tissue from people, are studied to understand health and disease. Clinical research helps find new and better ways to detect, diagnose, treat, and prevent disease.

    Clinical Trial, as defined by the NIH, is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. .

  4. Protocols that require UW Health facilities, staff, equipment, procedures, and/or patients; use SMPH resources or take place in any SMPH space involving human subjects?
    Examples of SMPH resources or space include imaging studies at WIMR, nutrition studies that recruit directly from the community

Keywordsfaq protocols enter OnCore Carbone Comprehensive Cancer Center UWCCC required requirement mandatory requirements CRU investigational   Doc ID12775
OwnerIlsa G.GroupSMPH Research Informatics
Created2009-11-30 19:00:00Updated2024-06-10 06:42:22
SitesSMPH Research Informatics , SMPH Research Informatics TEST
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