This project contains two objectives that satisfy the Clinical Trials Monitoring requirements of the FDA, HHS, PHS, NIH and the NCI policies and procedures concerning accuracy and quality assurance of data for Phase I Clinical Trials. The two objective are as follows: (1) to establish a detailed patient by patient data base for clinical observations occurring during Phase I trials and to provide regular status report and summary findings in a uniform format. The data base shall provide the Division of Cancer Treatment (DCT), NCI and the Phase I investigators timely information on ongoing studies, and it shall assure the DCT of quality data on all patients from all studies. (2) to provide """"""""site visit"""""""" monitoring of each Phase I contractor in order to assure the DCT of the Phase I Principal Investigators' compliance with the NCI policies and the FDA regulations regarding data quality; human protection procedures; and drug storage and accountability.
