PEDIATRIC PHARMACOLOGY RESEARCH UNITS

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The functions of the Central Operating and Management office are: (1) to integrate the operations of all thirteen units; (2) to meet or exceed reporting requirements of FDA and Pharmaceutical Companies; (3) to facilitate communications among the PPRUs, the FDA, and Industry (Pharmaceutical Companies and Contract Research Organizations); (4) to ensure that pediatric clinical trials are performed in a cost-effective and time-expedient manner; (5) to develop and maintain information systems for specified tasks; and (6) to monitor performance measured by specified parameters. The Central Office performs the following tasks: (1) Development and maintenance of a clinical trial data management system; (2) Development and maintenance of information system for the tracking and status for the acquisition, start-up, progress, completion, reports, summaries and labeling status of all drugs involved in PPRU studies; (3) Development of standard procedures manuals for data management; (4) Analysis and generation of reports as required by the FDA and pharmaceutical companies and development of an audit trail; (5) Analysis and generation of annual and customized reports; (6) Formulation of an adverse experience reporting system; (7) Development of standardized contract with pharmaceutical firms for all units; (8) Provide assistance in the negotiation and management of contracts with industry; (9) Assessment of current and future needs of the Network and assessment of growth, including fiscal and business projections; (10) Maintenance of compliance assessments, enrollment performance, and success rates of individual units; (11) Development of procedures to standardize site monitoring; and (12) Preparation and maintenance of all operating documents, policies, and procedures of the PPRU Network.