The Data Management Core will provide the following services to this Program Project: (1) register patients on protocol, enter basic clinical data into the data base, assess response and subsequent clinical status of patients, and (2) extend the current clinical data base to include data from the laboratory projects and assure the functionality and integrity of the data base. For purposes of patient registration on protocol and follow-up of subsequent response and survival, we will use established routines in the Leukemia Department at MDACC. These are overseen by experienced personnel and have been the basis for many publications. The existing leukemia data base contains pre-treatment, response, and survival data on > 1,000 patients with AML and has supported numerous publications. This data base resides on a VAX computer and is accessed via the VA Filemanager software package. Data from Blood and Marrow Transplant patients (Project 4) are transferred to the Leukemia Data Base as are data from the laboratory based research Projects 1-3. Laboratory data are assembled in an Access Data Base, which serves as a portal to the Leukemia data base. Fields for all ongoing projects have been developed. Data base dictionaries are in place, as are stringent QC and security measures. Routine audits are performed to insure that the database matches the primary research records in the laboratory. Files are transferred from Core D1 to Core D2 for biostatistical analysis. Dr. Stephen Condit, Systems Analyst from the Fred Hutchinson Cancer Research Center has reviewed the database and has agreed to serve as Consultant.
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