The Clinical Protocol Management Core (CPMC) provides expertise in the areas of protocol administration and data management to the investigators of City of Hope Comprehensive Cancer Center.
Specific responsibilities include planning and designing cancer-related studies with respect to protocol and data management issues, screening patients for eligibility and registering them on studies, managing studies in progress, collecting study data, monitoring regulatory compliance, assisting with IRB submissions, ensuring timely reporting of adverse reactions, assisting with preparation of data and review of reports for study analyses, and participating in training, continuing education and quality assurance procedures. All of these are carried out in compliance with the Good Clinical Practices, established in 1997 by the Food and Drug Administration.
A staff of 55.5 clinical research associates (CRAs) and data managers collaborate with clinical divisions and departments at City of Hope, including Hematology/Hematopoietic Cell Transplantation, Medical Oncology, Surgery, Pediatrics, Neuro-oncology, Gene Therapy, Urology, Palliative/Supportive Care, Radioimmunotherapy, Radiation Oncology, Clinical Cancer Genetics and our Outreach Program.
The Medical Information Database Analysis System (MIDAS), an in-house relational database, is the repository of all data collected on subjects on clinical trials at City of Hope. The CPMC is co-directed by Joyce Niland, Ph.D. and Dina Johnson. Daily technical supervision of the CPMC CRAs is provided by two clinical trials administrators. A quality assurance administrator and four quality control coordinators assist in training, review data, and conduct Protocol Adherence Evaluations of in-house trials.
An Outreach Program is staffed by three coordinators to collect data at our City of Hope affiliates and to manage our Minority Outreach Program. The operations specialists assist with policies and procedures, forms design, protocol reporting and maintenance of the Clinical Protocol website. The City of Hope ITS personnel support the central server, workstations, and software installations. Two senior data entry clerks provide entry of protocol administrative data as well as protocol specific results.
Last updated: 06/30/2008