ARTICLES BY BETSY FALLEN
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Edgy Observations On Clinical Site Documentation Management: Leading Or Bleeding?3/6/2018
For an investigational trial, clinical site documentation encompasses many types of records. These cover every aspect of patient care, policy guidance, and study execution. Not only does the patient medical history and care need to be maintained, but documentation supporting the plan and evidence of execution of a clinical trial must also be managed. This extensive collection of information is always subject to regulatory inspection.