Scheduling and Log Systems

Abstract

Medical facilities generate many records for purposes such as financial accounting, general administration, and supply dispensing that are needed to produce accurate reports on their business and medical activities. Records of transactions with research subjects, such as petty cash disbursements, appointment scheduling, and dispensation of medication for diagnostic procedures, serve a secondary function of corroborating data recorded on CRFs by reflecting the patient’s progression through the facility. When presented as supporting documents, these records engender confidence that CRF data submitted to the sponsor and the FDA are both accurate and authentic. Although investigators are not specifically required to maintain scheduling logs, it is wise to establish some combination of the administrative systems described below to support CRF data and serve as backup sources that can be used to resolve possible transcription or other documentation errors.