This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. Using current forms, ICH GCP information, FDA regulations, and other references, it shows readers how to manage a clinical research study effectively and efficiently. Chapters include: Overview of Clinical Research, FDA Regulations and Good Clinical Practice Guidelines, The Study: Planning Stages and Commencement, Interactions with the Sponsor, Interactions Within the Institution; The Role of the Study Subjects, Data Management: Adverse Events, Investigational Agent Management, and Inspection of Clinical Research Sites.
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