The National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS), is responsible for the clinical development of affective therapies for HIV infection and its sequelae. In order to meet this goal, two systems of clinical sites have been crated: The AIDS Clinical Trials Group (ACTG) and the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). The ACTG is a cooperative clinical trials program consisting of investigators in 47 academic research settings. CPCRA investigators are primary care physicians in 21 community-based health organizations. Together, the ACTG and CPCRA actively follow several thousands of patients each year in numerous research protocols. The Clinical Site Monitoring contractor will design, establish and administer a system for monitoring these clinical sits. This will include conducting quarterly visits to the sites to determine compliance with federal requirements and DAIDS standards pertaining to the collection of research data, Institutional Review Board and informed consent procedures, drug accountability and the clinical management of the sites. The accuracy and completeness of research data recorded by the site staff on case report forms will be verified through comparison to the patients' primary medical records. The contractor will submit written reports on site visit findings to DAIDS. The contractor will also design and conduct training activities for clinical research and protocol implementation for the clinical sites in cooperation with other DAIDS contractors.
