The Administrative Core will be responsible for financial and scientific aspects of the grant, including administrative and secretarial services for the individual projects and Clinical Core, as follows: a) administration of the Program Project Grant with respect to Federal and University regulations; b) disbursement of funds; c) annual reports; d) facilitation of progress and completion of all projects, coordination of individual projects, and coordination between projects; e) organization of regular meetings between investigators In addition, the Administrative Core will interact with the Clinical Core personnel to ensure seamless provision of data to the Project P.l.s and to facilitate protection of the safety of research subjects. New to the PPG are establishment of both an Internal Advisory Committee and a Data Safety Monitoring Board. Both will meet on a regular basis to evaluate the progress and to assure safety and efficacy of the individual projects. The DSMB will report their conclusions to the Project P.I., the Administrative Core personnel, and to the Internal Advisory Committee. Of note, for a number of reasons (protection of patient privacy, quality control, prevention of duplication of effort) access to the database is limited. We have clearly defined (our IRB approved) policies for access to the database. The database has security measures so that there are different types of access?no access, read only, data entry only, report writing (see attached manual). The Administrative and Clinical Core oversee access to the database and protection of safety of research subject.
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