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INFORMATION FOR

Protocol Review Committee

Purpose/Mission

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.

In addition:

  • 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.

2022 PRC I & II Meeting Schedule and Related Deadlines

Guidelines for Initial Submission

Guidelines for Amendment Submission

YCC Protocol Review Committee Charter


Protocol Review Committee (PRC I)

Chair: Amer Zeidan, MD

Vice-Chair: Hari Deshpande, MD

Protocol Review Committee (PRC II)

Chair: Antonio Omuro, MD

Vice-Chair: Pamela Kunz, MD

For information, contact:

Niece Hanna, MSW

Research Oversight Committee Regulatory Analyst

Yale Center for Clinical Investigation

2 Church Street South, Suite 409

203.785.7408

prc.ycc.committees@yale.edu

Dismayra Martinez, MHE, CCRP

Research Oversight Committee Regulatory Analyst

Yale Center for Clinical Investigation

2 Church Street South, Suite 409

203.737.3537

prc.ycc.committees@yale.edu