This grant requests funding for a Statistical Center for the Intergroup Rhabdomyosarcoma Study Group (IRSG), a pediatric cooperative clinical trials group conducting ongoing research in the treatment of pediatric rhabdomyosarcoma. The IRSG Statistical Center is comprised of the IRSG Biostatistical Center, located at the University of Nebraska Medical Center in Omaha, NE and the IRSG Data Management Center, located in Arcadia, CA. The Statistical Center is responsible for all biostatistical, data management, database management, and data quality control for the IRSG. Members of the Biostatistical Center collaborate with the IRSG Group membership on study design, on study statistical considerations, on the production of interim and final reports of Group research, and on the writing of abstracts and manuscripts for publication. Statistical Center statisticians also engage in collaborative and, where appropriate, statistician-directed research using the IRSG database. The IRSG Data Management Center (IRSG/DMC) has responsibility for patient registration, central data collection, data management and data processing, and data quality control. The IRSG/DMC also monitors significant events such as severe or unusual toxicities and assures compliance with adverse drug reaction (ADR) reporting mechanisms to facilitate patients safety monitoring by IRSG.
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