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Administrative Core

The ADCS Administrative Core provides administrative, fiscal, regulatory, and study participant recruitment and retention support for the organization as a whole. The Administrative Core plans and coordinates ADCS Steering Committee meetings, makes decisions involving policy, priority, the flow of work, and allocation of resources and personnel. Further, it develops and oversees the development of appropriate policies, procedures and the manual of standard operating procedures for the ADCS.

The Finance Unit of the Administrative Core provides fiscal control for the operations of the ADCS, generates payments to participating research sites for work completed, establishes and maintains contracts with vendors and research sites, and manages all aspects of ADCS grant proposal submissions.

The Regulatory Affairs (RA) Unit manages the regulatory complexities of ADCS clinical trials. The RA unit assists with protocol development and works with the Project Directors to ensure that the protocol meets all regulatory requirements, including those for the informed consent, HIPAA and NIH data-sharing requirements. The unit creates, reviews and assesses research material that is submitted to regulatory agencies, affiliated institutions and their Institutional Review Boards (IRB). Regulatory files are maintained at the Coordinating Center and include current IRB approvals and other critical essential documents for each project in which a research site is participating. Ongoing communication with the IRB, sponsors, the FDA and other regulatory agencies allows the RA unit to ensure submission and follow-up of appropriate documentation at the local level. The unit has designed a very thorough protocol initiation process and works with the study sites to work through this process in order for RA to release study drug/approve sites for subject enrollment. In addition, the RA unit oversees and collects Conflict of Interest reports for all members of the ADCS.

The Recruitment and Retention Team maximizes efficient enrollment of participants and subsequent successful retention. The recruitment coordinators use many well-thought-out techniques including newsletters, web-based communication, direct mail, press releases and placement of all studies on both public and private clinical study websites. They also provide training to the participating sites on recruitment and retention, public relations and making use of local media. Tools are provided for the sites, including reference cards, bookmarks, flyers, brochures, protocol-specific information sheets, videos and DVDs, and newsletters. The team monitors enrollment at each site and offers assistance for identifying recruitment barriers and potential target audiences.

The Information Technology and Software Development Unit develops technology solutions and manages computing infrastructure, network connectivity and security for ADCS. The staff researches and develops software systems for the ADCS such as the ADCS public website, the administrative website, the contact management system, the site payments system, the requisition management system and the asset tracking system, to name a few. It also provides technical services and support to the Administrative Core, Medical Core, Clinical Operations and ADCS Biomarker Lab.