Clinical Research Management Office

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CLINICAL RESEARCH MANAGEMENT OFFICE 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. Through these efforts the CRMO has established itself as the center of all activities related to KCC clinical trials. Specific aims of the CRMO include: ¿ Facilitate the development of clinical trials within the Kimmel Cancer Center ¿ Coordinate the preparation and submission of studies for review by the CCRC and the Thomas Jefferson University Institutional Review Board ¿ Collect, abstract, maintain and update data specific to patients entered into clinical trials ¿ Maintain a centralized data base of patients participating in Kimmel Cancer Center clinical trials ¿ develop and maintain an ongoing quality assurance program that will ensure the accuracy of data ¿ ensure that oncology clinical trials (studying the biology, diagnosis and treatment of patients with malignant disease) are conducted according to federal, state and institutional regulations ¿ provide information and administrative support to the Clinical Cancer Research Review Committee (CCRRC) and the KCC Data Safety Monitoring Board (DSMB) ¿ provide budget development and fiscal management of funded trials ¿ distribute information on active clinical trials to investigators and the general public through the KCC website ¿ Coordinate Multidisciplinary Working Group meetings ¿ Auditing of Investigator Initiated Trials The Kimmel Cancer Center had over 120 open clinical studies in the 1/1/06-12/31/06 time frame with a total accrual of 999 subjects; 287 to therapeutic and 712 to non-therapeutic and prevention trials. Investigator-initiated trials (therapeutic) patient accrual total was 168 while there were 651 patients accrued to non therapeutic investigator initiated trials and 90 patients accrued to cooperative group trials in the 1/1/06-12/31/06 time frame.