Protocol Review and Oversight Committee (PROC) for Clinical Research

Replacing the SOM CT feasibility process, the PROC is an online questionnaire that will assist investigators to determine the scientific, operational and financial feasibility of conducting their research focused on studies involving patients less than 18 years of age and/or involves a condition that is followed by pediatric providers (not including VCU Massey Comprehensive Cancer Center PRMC approved protocols)

PROC approval is required prior to IRB protocol submission.

PROC review will occur in a timely manner; the PI of the study should receive a review response within five (5) business days or less from the date of submission in the form of an email.  This emailed response will either indicate approval, suggest revisions, or deny approval (reasons will be provided).

The goal of the PROC is to provide a quick and concise review of your proposed study to ensure the best possible chance of successful enrollment and overall study success.

The PROC is charged with conducting an assessment of scientific merit: (Dr. Henry Rozycki, Department of Pediatrics Vice Chair for Research and Director of the Child Health Research Institute – VCU and William Koch, Associate Professor, Division of Pediatric Infectious Diseases); facilities feasibility: (Dr. Mary Harmon, Director of Clinical Research – VCUHS and a staff member from the Clinical Research Unit); and financial feasibility: (a staff member from the Pediatric Research Office). Specifically, the PROC will perform a high-level review of:

Scientific Feasibility:

• reviews the protocol for scientific merit with consideration of the benefits and risks associated with the protocol.

Operational Feasibility:

• Evaluates if appropriate personnel resources are available to conduct the study;
• Evaluates study population availability;
• Evaluates if there are any conflicting studies in progress;
• Conducts a high-level review of the costs needed to complete protocol activities and patient care visits are determined by the PI and/ or Coordinator.

Facilities:

• Evaluates if facilities and equipment are available and adequate to service the study;
• Evaluates if nursing services are available and appropriate.

Regulatory:

• Evaluates and make a determination of HSR vs NHSR.

FOR MORE INFORMATION, INSTRUCTIONS, FAQs, AND A LINK TO THE SUBMISSION PORTAL, please go to VCU OneTrac : https://onetrac.vcu.edu/ and select Children’s Hospital of Richmond.

Questions?  Please contact Dr. Henry Rozycki at henry.rozycki@vcuhealth.org or Dr. Mary Harmon at mary.harmon@VCUhealth.org