Review Process

Investigators interested in utilizing Clinical Research Center (CRC) resources may submit an application to the CRC Nurse Director, Mary Peterson, RN. The CRC is available for all qualified clinical research protocols approved by the UTHSC Institutional Review Board.

Pre-Review Process

CRC personnel filing

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 Nurse Director for review prior to receiving IRB approval. Also, the Office of Research Administration Route Sheet now 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 Investigator's request for preliminary costs, then meet with the CRC Nurse Director and Investigator or Coordinator (if needed) for review. The CRC Nurse 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 meet to review and discuss all aspects of the proposed protocol including but not limited to feasibility, nursing or personnel time, equipment needed, space required, timeline of projected project, and determine costs to implement. Once final determination of CRC resources is reached, the information will be relayed to the investigator.

Initial Review Process

After agency funding and IRB approval has been obtained, the Investigator will complete the required CRC application and documents and submit this information to the CRC Nurse Director. The CRC Nurse Director will forward the application and documents to the CRC Initial Review Committee. The Initial Review Committee consists of the CRC Director, Business Manager, and the CRC Nurse Director.

Study Initiation Meeting

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. Training and documentation of training of CRC staff 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 Nurse Director, Mary Peterson, RN who can be contacted at 901.516.7086 to set up the Study Initiation Meeting.

Methodist University Hospital

Clinical Research Center
Methodist University Hospital
1265 Union Avenue
8th floor East Wing
Memphis, TN 38104
Phone: 901-516-2212
Fax: 901-516-7013
Email: Bridgette Cain

Hours of Operation:

Monday through Friday
7:00 a.m. to 4:00 p.m.