GCP data quality for early clinical development.

Abstract

Good Clinical Practice (GCP) provides an internationally accepted standard to ensure subject safety and data quality in clinical trials. Much of GCP parallels ethical considerations that have accumulated in successive versions of the World Medical Association's Declaration of Helsinki. This document advocates for preservation of rights, safety, and well-being of human study participants. By contrast, GCP data quality provisions follow from evolution in the United States drug regulatory system during the 1960s. Evidence of fraudulent or otherwise biased data-gathering ultimately led to U.S. Food and Drug Administration (FDA) data integrity regulations that were subsequently embraced as GCP principles in the Declaration of Helsinki. This manuscript summarizes GCP data quality provisions and describes practices that clinical site investigators can adopt to comply with these principles and to prevent adverse audit findings in the event of a regulatory inspection.