Following these five rules will ensure that OOE investigations are conducted in a scientific and meaningful manner, with each instance providing a genuine opportunity for improvement.
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.