The CPDMO is a Shared Resource that provides a number of centralized clinical protocol-related services. The primary objectives are to support Cancer Center investigators by providing assistance in developing high quality clinical protocols, a centralized clinical trial registration system, design and development of case report forms and data entry screens, and monitoring of their trials. Services provided are available to all Cancer Center investigators. Protocol Development: The Protocol Development Coordinator (PDC) assists the investigator to ensure that he/she utilizes the appropriate protocol template. Standardized protocol templates for Phase II and III trials and for transplant and gene therapy trials are available. A specialized template for Phase I trials is being developed. Institutional informed consent templates also are available. The PDC ensures that all appropriate protocol sections are included and provides information regarding other studies that may be affected by the protocol. The PDC develops patient treatment roadmaps and calendars in conjunction with the PI. The Investigational Studies Pharmacist helps the PI develop pre-printed standardized protocol orders (available for all open protocols). Protocol Quality Assurance Coordinators (PQAC) work with PIs, statisticians and research analysts during development of the study to define data collection requirements and to design data collection forms and data entry screens. The PDC maintains an electronic history of protocols and related documents. Centralized Registration: A centralized patient protocol enrollment process was implemented in April, 1998. Investigators call the CPDMO and provide answers to all questions on the protocol-specific Eligibility Checklist prior to obtaining informed consent. The checklists are available on the SJCRH intranet for investigators to view and print. The automated patient protocol manager system (PPM) is now utilized for the study enrollment process. After ensuring protocol eligibility based on information provided during the phone call, an informed consent document labeled with the patient?s name and medical record number is generated automatically by PPM and delivered to the investigator by CPDMO staff along with a copy of the protocol and a protocol standard-order set. Investigators are expected to FAX the signed consent to the CPDMO within 24 hours of signature. E-mail notification of the study entry is sent to the study data manager and PI upon receipt of the signed consent copy. Protocol Monitoring and Auditing: Monitoring and auditing of clinical protocols are facilitated through the CPDMO. The CPDMO, as an independent Shared Resource within SJCRH, provides quality control functions including auditing of protocols and verification of primary data. Primary responsibility for data management resides in the individual Cancer Center Programs so that the oversight by the CPDMO is independent of the processes of conducting the clinical trial and collecting the primary data. Initial monitoring of protocol compliance includes source document verification of protocol eligibility for all enrolled patients. Ongoing monitoring of protocol compliance and data integrity will be conducted at intervals determined on a protocol by protocol basis or as needed according to the rate of patient enrollment. Clinical monitoring, which includes safety data evaluation, will consist of 100% verification of database records with source documents. The projected total budget for this SR in year-25 of this grant is $735,800, of which 34% ($252,571) is requested from the CCSG. The remainder of the budget (66%) will be provided by SJCRH institutional funds. The increase in funding requested over current levels largely reflects increased costs associated with study monitoring and the external DSMB.
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