Principles of Data Management

Abstract

The decision to participate in pharmaceutical research imposes regulatory responsibilities to document all clinical and administrative activities pertaining to a study. Appropriate arrangements also must be made to ensure the confidentiality of records and their long-term availability to regulatory agencies. Although these record-keeping requirements are rather extensive, methods can easily be devised to streamline data collection and recording so these administrative activities do not prove burdensome. The chapters that follow describe efficient systems for documenting clinical activities and regulatory communication. These methods provide audit points and quality assurance controls that are essential in any research operation.