Protocol Review Committee
Protocol Review Criteria
Scientific merit
- adequate background / rationale
- clearly defined research questions
- methodology
- design feasibility
- statistical power
Financial and budgetary issues
- contracts in place for pharmaceutical company-sponsored studies
- assurances of grant funding if indicated in the protocol
- resources needed to perform the trial are available and covered by the study budget
- likelihood of third party payment if no designated funding source
- Clinical and Translational Research Centers (CTRC) submission required if no reimbursement for research procedures is needed
Clinical care and patient management issues
- availability of resources as necessary to fulfill requirements of all timepoints of the protocol
- availability of patients:
- competition between proposed study vs. other studies for similar patient populations
- prioritization plan in place for such competitive protocols
- investigators' accrual goals achievable vs. relevant patient population at UPCI (non-competitive protocol)
