Investigator's Handbook: A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by the Division of Cancer Treatment, National Cancer Institute

摘要

Contents: Sponsors, research bases, and the investigator; The development of a clinical trial; The planning and execution of a clinical trial; The drafting of a protocol; Protocol review and approval at NCI; Ordering investigational drugs from NCI; Responsibility for reporting of results to CTEP; Adverse drug reactions; The organization of a clinical trial; The investigator and protocol chairman; Affiliate investigators; Who may administer investigational drugs; Accountability and storage of investigational drugs; Monitoring and quality assurance; Non-research use of investigational drugs; Special exceptions; Appendices.