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A1.0100 OVERVIEW OF UK RESEARCH ENVIRONMENT - page 17 / 23

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A1.0050

primary activity of the IDS is to ensure the appropriate procurement, storage, distribution, and inventory control of investigational and study drugs. Investigational drugs are those drugs which have not received FDA approval for use in humans. Study drugs are those FDA-approved drugs being used under protocol for human research, possibly outside of FDA-approved labeling. The IDS provides the support needed to assure safe and efficient conduct of clinical drug trials including compliance with federal, state, and Joint Commission on Accreditation of Healthcare Organizations requirements regarding investigational drugs. The IDS Director serves as an ex officio member of the Medical IRB; supplies pharmacy information to the IBC on some protocols, especially gene therapy protocols; and provides pharmacy support to the VAMC and the UK CR-DOC.

Upon initiation of a clinical drug study, the IDS requests a copy of the sponsor’s protocol and the investigator’s drug brochure. The research pharmacist reviews the protocol and meets with sponsor representatives, the investigator, study coordinator, and other study personnel to assess the potential IDS requirements. The IDS will not initiate a clinical drug study without documentation of IRB approval.

A1.1950 UK CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE

The Center for Clinical and Translational Science (CCTS) facilitates community-participatory research and the translation of medical discovery to application. As an academic home for clinical and translational science, the CCTS co-localizes core research support and training infrastructure to facilitate sound research design, fiscal and regulatory compliance, and research integrity in CCTS-supported initiatives. This broad-based infrastructure for regulatory and compliance support within the CCTS includes the CR-DOC, a Regulatory Support and Research Ethics unit, and a Biostatistics, Epidemiology, and Research Design unit.

A1.1975 Clinical Research Development and Operations Center

The CR-DOC provides the CCTS and the clinical and translational science community with comprehensive clinical research infrastructure and operations support. CR-DOC inpatient and outpatient services and units facilitate study development, budget development, monitoring, regulatory compliance, participant recruitment, and specialized research staff education.

The Research Development Unit and the Regulatory Unit assist investigators supported through the CR-DOC in completing institution-wide regulatory requirements, including IRB submissions, budgets for industry-based trials, grant management, and all other aspects of study initiation and maintenance. Specific responsibilities are to ensure FDA/IRB and good clinical practice (GCP) compliance, monitor/audit studies for protocol compliance and patient safety, and monitor/audit Investigational New Drug applications and Investigational Device Exemptions. The Clinical Operations Unit provides nursing and coordinator services in the conduct of all phases of clinical trials, including research and consent procedures, adverse event surveillance, and data collection. Both units interact with other departments actively involved in oversight of clinical research including the ORI, the IRB, OSPA, Sponsored Projects Accounting, the IDS, the VAMC, the RSC, and other applicable units.

The CR-DOC also provides education and training for study personnel on fiscal compliance, GCP, study coordination, and human research protection. The CR-DOC provides support in creating effective recruitment plans, strategic marketing campaigns, and recruitment guidance to

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