The Treatment Branch of the AIDS Program of the NIAID has awarded 14 contracts to establish AIDS Treatment Evaluation Units to perform clinical, toxicological, pharmacokinetic, microbiological, and immunologic studies of candidate drugs for the treatment of AIDS. Due to the complexity of these efforts, a Clinical Trials Coordinating Center is needed to provide a central data management resource to be utilized by the staff of the NIAID, the Coordinating Center, and the clinical investigators of the Treatment Evaluation Units. The specific functions of the Coordinating Center will be to develop the necessary solftware necessary for receiving, processing, editing analyzing and storing study data from the ATEUs. Training, as required for the ATEU staff or NIH staff will be the responsibility of the Coordinating Center. Case report forms will be designed and developed for all the clinical protocols to be undertaken at the ATEUs. In addition, the Coordinating Center will implement procedures for tracking the disbursement of study drugs from the drug repository to the ATEU pharmacies so that regulatory concerns are met. They will also coordinate the collection of all necessary information from the investigators required by the FDA for the study of investigational agents. A physician monitor will be an integral part of the Coordinating Center's staff. This individual will be responsible for site visit monitoring the Treatment Units twice each year to insure that protocols are being followed and FDA requirements are being met. Additional site visits will be done specifically for the purpose of data audits; these visits will be designed to monitor the quality control of data collected as it relates to accuracy. The staff of the Coordinating Center will work directly with Institute staff and investigators from the ATEUs to develop procedural aspects of these studies and will prepare and distribute a detailed Manual of Procedures to describe all activities related to these efforts. Regular reports will be prepared by the Coordinating Center which contain necessary information concerning the progress of ongoing studies. Separate reports will also be prepared for review by the Data and Safety Monitoring Board.
