STATISTICAL SUPPORT UNIT

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2.6.3.3 NCCTG Statistical Data Center The NCCTG Statistical Data Center (SDC), under the direction of the Group Statistician, Daniel J. Sargent, Ph.D., is comprised of two units: the Statistics Unit and the Data Systems Unit. The two units function in a highly coordinated fashion under the leadership of Dr. Sargent and the Group Operations Coordinator. Together, these two units provide statistical collaboration, data management support, and information technology (IT) support for the development and conduct of NCCTG cancer clinical trials, including translational research. The Statistics Unit exists within the Mayo Clinic Cancer Center (MCCC) Biostatistics Shared Resource, also directed by Dr. Sargent, where statistical support for multiple programs provides synergies that benefit all. There are over 40 individuals currently in this shared resource. The NCCTG Statistics Unit currently consists of portions of 8 Ph.D statisticians, 9 master trained statisticians, 10 statistical programmer analysts (SPAs).and 2 administrative assistants. The Data Systems Unit, under the direction of Ms. Paulson, exists within the MCCC Clinical Research Office Shared Resource that includes over 140 individuals. Again, the high degree of interaction provides synergies that benefit all. The NCCTG Data Systems Unit is comprised of three subgroups: 1. Programming Unit with 17 Analyst/Programmers. 2. Data Coordination Unit with 4 Data Management Specialists and 1 Administrative Assistant. 3. Clinical Trials Coordination that includes the Quality Control Unit, the Randomization Unit, and the Compliance Unit. The Quality Control Unit includes 18 Quality Control Specialists,'the NCCTG SAE Coordinator, the NCCTG Pathology Coordinator, the NCCTG Surgery Coordinator, and 1 supervisor. The Randomization Unit includes 3 Randomization Specialists. The Compliance Unit includes 2 Compliance Specialists. While the personnel within the Compliance Unit are considered members of the Data Systems Unit, their activities are defined by the NCCTG Audit Committee.