Abstract:Chapter 18 The Clinical Trial Protocol and Amendments Karen A. Henry, Karen A. HenrySearch for more papers by this author Karen A. Henry, Karen A. HenrySearch for more papers by this author P. Michael...Chapter 18 The Clinical Trial Protocol and Amendments Karen A. Henry, Karen A. HenrySearch for more papers by this author Karen A. Henry, Karen A. HenrySearch for more papers by this author P. Michael Dubinsky, P. Michael Dubinsky Spartansburg, PA, USASearch for more papers by this authorKaren A. Henry, Karen A. Henry University of California, Berkeley, Richmond, CA, USASearch for more papers by this author Book Author(s):P. Michael Dubinsky, P. Michael Dubinsky Spartansburg, PA, USASearch for more papers by this authorKaren A. Henry, Karen A. Henry University of California, Berkeley, Richmond, CA, USASearch for more papers by this author First published: 29 December 2021 https://doi.org/10.1002/9781119772682.ch18 AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Summary This chapter focuses on the contents of and the operational activities involved in developing a clinical trial protocol to meet the regulatory requirements. It describes the context for a protocol in clinical development, the purpose of a protocol in a clinical trial, the contents of a protocol, the process for developing a protocol, changes to a protocol, and the principles for implementing a protocol or amended protocol. The clinical trial protocol is the investigational plan for the trial. The plan is carefully designed to safeguard the health of the participants as well as answer-specific research questions. The administrative and business contractual information may otherwise be contained in a clinical trial agreement. Monitoring participants' safety is the foremost responsibility of all players involved in the conduct of a clinical trial. Several considerations to enable quality-by-design principles can be factored into the design and operationalization of a protocol. The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice RelatedInformationRead More
Publication Year: 2021
Publication Date: 2021-12-29
Language: en
Type: other
Indexed In: ['crossref']
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