Abstract
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.
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