This contract supports the Therapeutics Research Program (TRP), within the Division of Acquired Immunodeficiency Syndrome (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID). The Contractor shall establish and maintain a Clinical and Regulatory Operations Center (CROC), which will support the AIDS Clinical Trials Groups (ACTG), the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA), the AIDS Vaccine Evaluation Group (AVEG), the HIV Vaccine Efficacy Trials Network (HIVNET) and the intramural Research Program (IRP) with regulatory and technical functions related to drug and vaccine clinical trials. Major project activities will include assembly and submission of INDs, amendments and annual reports; coordination of adverse experience reporting, initial medical evaluation of adverse experience reports, research assistance for preparation of safety reports and other research synthesis; coordination of site registration; and operational support for the AIDS Clinical Drug Development Committee and development of clinical trials agreements between industry and DAIDS. In addition, the CROC will provide technical support for DAIDS reviews of concept sheets and final protocols for the ACTG, CPCRA, and DATRI; provide technical support for Data and Safety Monitoring Boards; arrange logistics for national ACTG scientific meetings, and maintain a management information system for rapid retrieval and distribution of information related to the centrally coordinated activities.
