Core Center Resources:
Resources for Clinical Research Management
Clinical Research Management Office – Maureen Morgan, M.S., KCC, TJU
The Clinical Research Management Office (CRMO) is a shared resource of the Kimmel Cancer Center (KCC). The CRMO collaborates with physicians, scientists and support staff in the development and implementation of Kimmel Cancer Center clinical trials. The CRMO staff provides a broad range of services tailored to the specific needs of the investigator and his/her support staff.
The CRMO staff has developed close working relationships with the KCC disease-specific multidisciplinary working group leaders, individual investigators, members of the TJU Institutional Review Board, the TJU Office of Research Administration and Office of Sponsored Programs.
Both CRMO and Interactive Research Staff members are responsible for the organization and facilitation of the disease-specific multidisciplinary working group meetings. This has established the CRMO as the central resource for Kimmel Cancer Center clinical trials. CRMO staff, other relevant clinical trials staff, and representatives of the KCC Informatics Shared Resource meet monthly to discuss issues or concerns specific to Kimmel Cancer Center studies.
CRMO staff and other KCC interactive clinical trials staff also attend monthly educational meetings sponsored by the TJU Office of Clinical Trials designed to standardize best clinical trial practices across the entire TJU campus. The CRMO study coordination and data management staff meets weekly to review clinical trial process issues, sponsor requests, PI requirements, and other new or ongoing issues pertaining to the conduct of KCC clinical trials. The CRMO regulatory and financial staff meets to discuss clinical trial related issues on an as needed basis. The CRMO Director also chairs a meeting that addresses the status and progress of all KCC trials as they move from CCRRC, through IRB, to contract and budget negotiations.
The Protocol Continuum All CRMO management and functions are designed to support the various stages of protocol activity. Depending on the type of study (IIT, Cooperative group or pharmaceutical sponsored) and the needs of the PI, different CRMO staff members have well defined roles and responsibilities as a protocol moves from concept through study initiation to study closure.
- Study Concept: The CRMO staff meets regularly with Kimmel Cancer Center (KCC) physicians individually or through participation in multidisciplinary team meetings. They discuss potential new studies that may be initiated by KCC investigators, offered by cooperative groups, or sponsored by the pharmaceutical industry. CRMO staff identifies potential competing trials, and projects staffing requirements.
- Statistical Review: For KCC Investigator Initiated Study (IIT) concepts that are approved by the multidisciplinary team leader, the Biostatistics Shared Resource provides a statistical review and comment. The statistical review includes a detailed description of the statistical methods proposed to analyze the study results and a determination of the sample size required to complete the study.
- Clinical Cancer Research Review Committee (CCRRC) review: KCC Investigators submit all new research proposals involving human subjects to the CRMO. The pertinent disease specific working group provides a written statement evaluating protocol feasibility, lack of competing protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals before it will be accepted for CCRRC review. The CRMO staff prepares the documentation and coordinates communication with the CCRRC. The CCRRC is responsible for the initial scientific review of each proposed study looking at four basic issues: (1) study value; (2) methods; (3) investigator(s) experience and (4) patient resources. The CCRRC considers one of five actions in reviewing each study: (1) approved as written, no changes required; (2) approved with advisory changes only, no further committee action required; (3) approved in concept with changes or justification requested; (4) tabled for additional investigator input/clarification or (5) rejected. (This process is described in the Protocol Scientific Review and Monitoring System section of the application.)
- Thomas Jefferson University Institutional Review Board Review: Once a protocol is approved by the CCRRC, the CRMO regulatory staff prepares the study for submission to the Thomas Jefferson University Institutional Review Board (IRB). This involves preparation of the regulatory documentation required by the IRB as well
Clinical Research Services – Greg Stets, B.S.N, M.H.A., Nemours
The Clinical Research Services Core (CRSC), led by Greg Stets, is an outgrowth of the Nemours Clinical Pharmacology Research Program, which was originally developed to provide oversight and facilitation of clinical trials for Nemours investigators. With the development of the Center for Pediatric Research and support by the COBRE award, the CRSC has expanded to include four full time Clinical Study Coordinators including Sandra M. Budd, B.S., M.T., C.C.R.C., Dawn S. Brown, M.S.N., R.N., C.C.R.C., Coralee Karmazyn, R.N., B.S.N., C.C.R.P. and Lynn Marrs, R.N., B.S.N., C.C.R.C. The Coordinators directly serve the needs of both Center investigators as well as other Nemours investigators whose research involves human subjects, including children. They assist with study design, subject recruitment, database management, and also facilitate interactions with the Institutional Review Board by working with the target investigators and other Nemours faculty on protocol development and consent and assent documents to ensure that they meet institutional and federal requirements.