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  • An ordered program of clinical trials, each with specific objectives. This plan describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. (Adapted from ICH E8, E9) EXAMPLE(S): OTHER NAME(S): NOTE(S): The plan should have appropriate decision points and allow modification as knowledge accumulates.
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