Operations and Collaborations Center - Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Operations and Collaborations Center (UM2 Clinical Trial Optional)

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ABSTRACT – OPERATIONS AND COLLABORATIONS CENTER (OCC) The primary goal of the Operations and Collaborations Center (OCC) for the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) is to provide overall support for the ATN research program. The ATN OCC will work collaboratively with the ATN Scientific Leadership Center and the Executive Committee (EC) in developing and implementing the ATN scientific agenda through establishing and maintaining the ATN operational infrastructure, providing organizational support, and ensuring site consortium (SC) capacity for the ATN's research projects and with external collaborations. The specific aims for the OCC are: (1) support the ATN infrastructure including facilitate ATN-wide communications, support the EC and formation of subcommittees, schedule and organize routine and ad hoc meetings, including semi-annual Network meetings; and assemble and convene the ATN External Scientific Panel at least annually; (2) train SCs on research- related topics including regulatory, Investigational New Drugs (INDs)/investigational device exemption (IDE), safety reporting, good clinical practice/good clinical laboratory practice, human subjects protection, quality control (QC), and quality assurance procedures; (3) create mechanisms to monitor subject recruitment, retention, and dropout, and develop procedures for adjustment if enrollment targets are not being met; (4) build a detailed system to track and report study progress to the ATN EC and the National Institutes of Health, including a description of performance metrics, milestones, timelines, and QC measures, and strategies to identify and mitigate any issues; (5) liaison with the ATN EC to produce and maintain a Network Manual of General Operations, including standard operating procedures and policies; (6) provide and lead full regulatory structure to support all ATN and cross-network investigational (IND/IDE) clinical trials; (7) Maintain the ATN protocol disbursement fund and execute all necessary agreements to support site-specific subject accrual visit reimbursement, reconciling reimbursement with site performance, recruitment, and retention; (8) manage ATN resources and execution of performance-based subcontractors such as material distributors, specimen storage, pharmaceutical vendors, investigators; (9) develop and maintain a publicly accessible and restricted website to share information among the ATN and collaborating investigators; (10) establish and support a National Community Advisory Board (CAB) and provide logistical support for all CAB activities and meetings; (11) develop and support cross-network protocols, collaborations, and other projects, including the conduct of trainings and development of manuals of procedures, facilitating communications and conference calls; (12) oversee SCs, and support staffing and structure modifications as necessary to meet the evolving needs of research protocols; and (13) collaborate fully and with transparency, including appropriate sharing of all necessary tools, materials, technologies and other essential methodologies necessary for protocol and program development, implementation, and monitoring across the Network and with other networks.