To provide administrative, data management, quality control and statistical support necessary to successfully conduct clinical trials. Activities will include the following: a) To provide administrative support to all groups functions b) To interact closely with NCI personnel in all aspects of monitoring and reporting program activities c) To provide administrative support for committee and working group activities d) To provide financial support for foreign members and unfunded domestic members to provide or continue to provide follow-up data on study patients e) To collaborate with clinical investigators on the statistical and scientific aspects of planning new studies f) To develop data collection forms g) To establish the data base necessary to monitor and track heavy particle clinical trials h) To register/randomize patients and perform study specific eligibility checks via telephone i) To provide data management for the review and verification of all required patient data j) To manage the quality control program for heavy charged particle clinical trials k) To develop and maintain the computer software necessary for statistical analysis l) To monitor both active and closed studies under followup, to prepare interim statistical reports and appropriate analysis for the reporting of both initial and long term treatment results m) To maintain and monitor a late effects registry of all patients receiving heavy charged particle therapy Long-term objectives of the project is to assess local control, survival, and acute and late effects in normal tissues for a limited number of tumor sites which presently are not controlled by conventional treatment.
