The PRC is charged with the scientific evaluation of all cancer clinical protocols and amendments proposed at Yale prior to initiation. PRC review encompasses an assessment of the scientific rationale and merit of a proposed study in addition to protocol design, safety parameters, and biostatistical analysis to determine that high quality and appropriate designs have been incorporated. The review of the informed consent document focuses on scientific accuracy and ensures subjects are informed of risks, side effects and any alternative treatments.
- The committee assigns a priority score that considers scientific merit and other available studies and is based upon an averaged points system.
- The committee assigns a Data and Safety Monitoring Plan (DSMP). This plan consists of an audit schedule and a timeline for the PI to submit data and safety monitoring reports for review by the Data and Safety Monitoring Committee (DSMC). The DSMP takes into account the risk of the study using a risk assessment score sheet.
Amendment Submission Form Guidance>>