Effective data monitoring entails more than reviewing data residing in the databases. It also involves monitoring every step and process involved in collecting the data. Data monitoring is a constant, continuous, and necessary activity in any clinical trial. To prepare for this Discussion, review the components and standards for a data management plan, as described in the chapter titled “Data Management Plan” in the Course eBook, Good Clinical Data Management Practices. Reflect on the planning that should take place prior to the enrollment of study subjects and consider the impact and importance of data monitoring in a trial. By Day 4, post a comprehensive response to the following: Is it appropriate for the CRA to be involved in the creation and review of these documents? If so, explain why. If not, explain what the exceptions would be and why.
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