Clinical Research: From Proposal to Implementation

This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publicize the results of clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. It familiarizes readers with the regulatory aspects of human research and the procedures involved in investigational new drug and device applications. The authors provide a working knowledge of how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on the collection, quality control, and analysis of research data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature.