Core A: Administration and Clinical Trial Coordination Core

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Core A (Administration and Clinical Trial Coordination Core): Project Summary/Abstract Core A will serve as the administrative hub for the entire Program Project Grant. Core A will be responsible for all fiscal matters related to the Program and will interact with all of the Project and Core Leaders, administrative officials at Stanford University as well as NIH Officers to ensure smooth and thorough oversight of research and clinical operations, fiscal and regulatory matters. Core A will organize and run a monthly Program Project meeting where each Project and Cores B and C will be presented to the group once to twice yearly. Core A will also organize a yearly day long External Consultants Visit where each Project and Core will be presented in depth to our external advisors for their critique and review. A written summary will be provided and distributed to appropriate investigators. Core A will also be responsible for coordinating the proposed clinical trials by standardizing interactions with the Stanford University IRB, FDA where indicated, Stanford Cancer Institute and NIH Officials. Core A will be responsible for developing order sets for the clinical aspects of the studies, consenting eligible patients, reporting severe adverse events to appropriate regulatory bodies and supporting data management with Core B. Core A will also work with the Stanford Cancer Institute to enhance awareness and enrollment of eligible women and minority patients to the clinical trials described in this application. Core A will monitor scientific and clinical progress of the Projects and when needed coordinate necessary changes and revisions as well as ensure availability of Core B and C resources to all of the Projects utilizing those services. In summary, Core A is integral to the organization, coordination and implementation of this PPG.