Review Process
The CRC Pre-Review Process is the first review of information submitted for Clinical
Research Center resources. Once a request is received for CRC services, a pre-approval
process begins. Information may be sent to the CRC Unit Director for review prior
to receiving IRB approval. The Office of Research Administration Route Sheet includes
a "box" to be checked if CRC resources will be requested. The Pre-Review Committee
will assess these projects for resources and services needed.
The CRC Director will review the request for preliminary costs, then meet with the investigator or coordinator (if needed) for review. The CRC Director will review the protocol and determine clinical staffing requirements, laboratory needs, and projected costs for the project. The CRC Director and CRC nurse director will review and discuss all aspects of the proposed protocol including feasibility, nursing or personnel time, equipment needed, space required, timeline of project, and determine costs. The investigator will be notified once final determination of CRC resources is reached.
A Study Initiation Meeting is required for each Principal Investigator and Research Coordinator of approved CRC projects prior to study implementation. The Principal Investigator will review the protocol with all CRC staff members for questions or comments. CRC staff training and training documentation of study specific metrics is required before the initiation of the new protocol.
Training documents for each CRC staff member for each study will be kept by the CRC Unit Director, Ruben Cuervo, MD (contact at 901.516.7086 to set up the Study Initiation Meeting).