The Clinical Protocol Compliance/Quality Review and Data Management shared resource was first funded at the time of the CCSG renewal in 1995. This resource provides a wide range of services in support of therapeutic clinical trials, including assistance with protocol development, compliance monitoring of ongoing protocols, programs for all staff involved in the conduct of clinical research. All of these activities have expanded over the past 4 years, and with the planned start up of a Protocol Information Center (telephone services for patients and physicians calling in for RPCI clinical trial information), the development of the Community Network of Physicians who wish to enter patients on RPCI clinical trials, and the new Multicultural Program for Development of Health Care Initiatives, the major emphasis of which will be the recruitment of women and minorities to clinical trials, the renewal budget for this shared resource includes the addition of a research nurse/data manager. This person will assist new investigators in protocol development and initial data management activities of a protocol. As needed, this person will also be assigned to the other ongoing activities and the three new initiatives mentioned above which will be supported through the Protocol Office and this shared resource. RPCI is now converting to a new Hospital Information System which will significantly benefit the Protocol Office with greater efficiency, flexibility and quality of data management. This system will also enable the Protocol Office to conduct cost analyses, in real time, of ongoing clinical research, and will enable the analysis of outcomes in protocol patients versus comparable non-protocol patients. However, this conversion will be complex and time consuming. Given the long-range importance to clinical research of this conversion, and the need to maintain current database management and computer capabilities throughout the conversion process, the budget requests an increase in salary support of the Database Manager/Computer Programmer from 30 to 50%. This individual will also be involved with the set-up and maintenance of databases and computer operations for the three new initiatives mentioned above. The three positions requested through this CCSG budget are extremely important for this expanding shared resource.
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