Description
This handbook focuses on using electronic data capture when conducting controlled clinical trials of a new drug or medical device before it goes on the market. The author provides guidelines for every step in planning a clinical trial, such as forming a design team, specifying eligibility requirements and safety measures, obtaining regulatory agency approval for the trials, recruiting physicians and patients, and selecting software for data entry and storage. The final chapters discuss monitoring the trials and analyzing the final data. Annotation (c) Book News, Inc., Portland, OR (booknews.com)
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This engaging and non-technical guide to clinical trials covers issues study design, organization, management, analysis, recruitment, reporting, software, and monitoring. Free from the jargon-laden treatment of other books, A Manager’s Guide to the Design and Conduct Clinical Trials is built upon the formula of first planning, then implementing, and finally performing essential checks. • Offers an executive level presentation of managerial guidelines as well as handy checklists accompanied by extracts from submitted protocols • Includes checklists, examples, and tips, as well as a useful appendix on available software • Covers e-submissions and use of computers for direct data acquisition • Incorporates humorous yet instructive and true anecdotes to illustrate common pitfall
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