CENTRALIZED PROTOCOL AND DATA MANAGEMENT UNIT

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The CPDMU is a shared AECC resource widely used by members from the various oncologic disciplines to perform clinical and translational trials. The CPDMU plays a central role that supports other components of the clinical trials infrastructure including the Protocol Review and Monitoring System (PRMS), Protocol Specific Research Support (PSRS), and Data and Safety Monitoring Committee (DSMC). The CPDMU administrative office is located on the second floor of the Weiler Division of Montefiore Medical Center (MMC), and is immediately adjacent to the administrative office of CPDMU Director and to the Chanin Cancer Research Institute. The CPDMU performs the following functions: protocol submission, regulatory affairs, data management and development, facilitates interactions with the Bioinformatics and Biostatistics Shared Resources, provides quality control, and serves as a resource for AECC investigators who require assistance in the design of clinical trials. Services provided include: cataloging, preparing, and submitting all new clinical protocols, informed consent documents, and HIPAA authorization documents to the PRMS and to the AECOM CCI and/or MMC IRB. Additional services include preparing a Spanish version of informed consent documents, conforming to CCI/IRB guidelines for a fully translated consent for non-English speaking subjects cataloging and submission of all amendments, collection, processing and distribution of all internal and external adverse events including distributions to IRB and governmental agencies, initiation of all new clinical protocols, submission of sequence numbers to pharmacy (insuring that all patients enrolled in clinical trials are properly entered into the clinical database), overseeing eligibility check, registration and enrollment of new patients, overseeing proper collection of data, recording of toxicities, dose modifications, performance of tests in a timely fashion, submission of forms in a timely fashion, and scheduling and performance of follow-ups. There are approximately 25 F.T.E. CPDMU staff funded by the CCSG. Clinical trials are supported by a N01 Phase II Contract (CA CM-17103), ECOG U10 grant (CA14959), AIDS Malignancy Consortium U01 core site subcontract, along with funding from investigator-initiated NCI and pharmaceutical industry studies.