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.
Managing the investigator payment is one of the most challenging aspects of running a clinical trial. Major factors considered by pharmaceutical and biotech companies for investigator payments are therapeutic area of interest, duration of the trial, clinical phase, and patient enrollment.