CORE--Biometry and Data Management

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Biometry and Data Management provides support. It consists of Biometry, Data Management and Participant Long-Term Follow-Up. These components collaborate very closely, and the personnel regularly interact with each other regularly. The objective is to provide biostatistical and computational support to the CCPPP, including biostatistical design and review of all clinical and laboratory studies, sample size calculations, development and maintenance of statistical databases, and study progress and outcome reports. The goals of Data Management and Long-term Follow-up are to collaborate with project investigators and staff in the provision of data management and follow-up of participants beyond the intervention period of the study. The responsibilities include the design and development of questionnaires, data entry and database maintenance, production of data files for investigator analyses, documentation of data collection and data management, generation of adverse event reports for data safety and monitoring, completion of medical record abstraction and forms, and participant follow-up for those who terminate the intervention or complete the trial. The Biometry and Data Management is essential to the projects of the CCPPP, as it provides study design and data analysis, assistance with form/questionnaire development, and overall data management and follow-up of participants beyond the intervention. In addition, Biometry and Data Management provides operational and regulatory reporting, provision of fully documented data files for analysis, provision of data for matching with specimens and collection of tumor slides and blocks, study design, and data analysis. As such, Biometry and Data Management is a critical component of the CCPPP.