Study Plan - Definition
Each study must have a comprehensive study plan, sometimes referred to as the protocol, which is the output from the study planning process.
Study plan means a document which defines the objectives and experimental design for the conduct of the study and includes any amendments
For each study this written plan should exist prior to the initiation of the study, and be approved by key stakeholders in the study.
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The approval of test facility management and the Sponsor may also be required depending on national legislation. Some organisations choose to add such approvals routinely to all study plans.
