Data Management Core

The Data Management core activities are performed by the Data Management Center of the ECOG- ACRIN Statistics and Data Management Center. The Data Management Center is responsible for collection and processing of data on ECOG-ACRIN studies and for related information systems support. The Center has two components. SDMC-EAMRF at the ECOG-ACRCIN Medical Research Foundation has primary responsibility for therapeutic studies. The SDMC-ACR at the American College of Radiology has primary responsibility for diagnostic and imaging studies. All clinical data on studies activated since the start of the NCTN is collected and managed in Medidata Rave, the NCTN's common Clinical Data Management System. ECOG-ACRIN has been a leader in developing configuration standards and operational procedures for using Rave in the NCTN. Data review procedures are well developed and include clinical review, which is usually performed by study chairs. The Data Management core has established extensive education and training programs for site personnel and investigators. These training programs are an important part of ensuring timely and accurate data submission and review. The data management core has also developed reports for monitoring site performance regarding timeliness and accuracy of data submission, and works with the ECOG-ACRIN Operations on the annual institution evaluation. The Statistics and Data Management Center also fully utilizes standard NCTN tools, such as the Oncology Patient Enrollment Network (the web interface for patient enrollment on NCTN studies), the Cancer Data Standards Repository library of standardized data elements, the common toxicity criteria for adverse events, the CTEP-AERS system for adverse event reporting, which is being integrated into Rave), and the Clinical Data Update System for reporting selected trial and patient data to NCI. The Information Systems group maintains multiple databases, develops and maintains tools for monitoring, reporting, and communication, and has developed infrastructure to support complex trials such as NCI- MATCH.