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There is a second type of protocol quality that is focused around the quality of the execution of the clinical trials. "Execution" quality addresses issues such as whether effective practices and processes are being used in the protocol; whether the protocol can be executed within the time and cost specified; whether the inclusion/exclusion criteria, procedures, visit schedule, etc. are necessary for the achievement of the protocol's goals and endpoints; and whether any of those events will hinder execution tasks such as subject enrollment/retention or data collection. While execution quality doesn't deal with the protocol from a scientific standpoint, it is nonetheless critical to a successful outcome. No matter how good the science is, a protocol that can't be executed effectively has very little real value.




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