Review Process

Investigators interested in utilizing Clinical Research Center (CRC) resources may submit an application to the CRC Nurse Director, Carolyn Alice Milem, 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 CRCC 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, Research Subject Advocate, CRC Nurse Director, and the Behavioral Intervention Director.

Initial Review Committee

Name Position Phone Number
Dale, James, MD CTSI Executive Director 901-448-2101
Dagogo-Jack, Samuel, MD CRC Director 901-448-2608
Christensen, Michael, PharmD PCRU Director 901-287-5355
DeBon, Maggie, PhD Behavioral Intervention Director 901-448-7144
Ramsey, Risa, PhD CRU Administrative Director/RSA 901-516-2079
Poulos, Jane, BBA Business Manager 901-448-3746
Pitts, Kathy, RN Nurse Director 901-516-2214

After the Initial Review Committee meets to review the application, written comments and concerns about the application, project, and services requested will be compiled. The Initial Review Committee will review the written report for further approval/non-approval and additional comments and discussion if needed. A decision will be made if further review will be required from the Scientific Advisory Board (SAB). Feedback from the CRC Initial Review Committee will be given to investigators who apply for CRC resources and investigators will have the opportunity to address all unresolved issues.

The Review process should take approximately seven to ten days to complete. The length of time to process applications will be tracked on the Protocol Review and Outcome Form. If the application is approved, the protocol will be forwarded to the Executive Management Board for council-level review and formal documentation of protocol approval. Approval letters will be sent to the PI of the proposed project and to the Research Subject Advocate.

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 in the CRCU.

Training documents for each CRCU staff member for each study will be kept by the CRC Nurse Director, Carolyn Alice Milem, RN who can be contacted at 901.516.2214 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.