ADMINISTRATIVE AND MEDICAL CORE A.
SPECIFIC AIMS The specific aims of the Administrative and Medical Core (AMC) are as follows: 1. Provide supervision and direction for the project as a whole. 2. Coordinate the activities of the clinical performance sites and the Project Directors with each other and with the Data Core. 3. Coordinate the meetings of the Steering Committee (SC), the Oversight Group (OG) and other groups. 4. Make decisions involving policy, priority and the flow of work, allocation of resources and personnel. 5. Provide fiscal control for the operations of the ADCS, including making site payments. 6. Coordinate the development and implementation of new protocols. 7. Develop appropriate policies, procedures and manuals as required such as: conflict of interest guidelines, publication policies and manual of standard operating procedures. 8. Oversee and support the activities of the various committees including the Protocol Committee, Data and Safety Monitoring Board (DSMB), Internal Ethics Committee, etc. 9. Evaluate the need to add or delete sites to maximize efficiency. 10. Develop and implement informed consents for each protocol, maintain and monitor regulatory documents, support IRB applications at sites and distribute safety reports. 11. Establish and maintain subcontracts with sites and vendors. 12. Develop and implement recruitment strategies and programs for each protocol. 13. Maintain contacts with industry, the media and the NIA. 14. Provide general medical and regulatory supervision for the clinical trials undertaken by the ADCS. 15. Code medical adverse events (AE) using FDA preferred terminology. 16. Classify concomitant medications used in ADCS clinical trials with a standardized classification scheme and nomenclature to assess potential drug interactions and safety. 17. Provide scientific and medical support for FDA IND applications, and other granting agencies. 18. Provide clinical trial safety reports to the DSMB 19. Provide clinical and medical expertise in ADCS negotiations with clinical laboratories, pharmaceutical corporations and corporate/private sponsors.
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