Ensuring Good Statistical Practice in Clinical Research: Guidelines for Standard Operating Procedures (An Update)

Abstract

In 1994, the Statisticians in the Pharmaceutical Industry published Guidelines for Standard Operating Procedures (GSOPs) on good statistical practice in clinical research. Background and rationale for the GSOPs and the latest release of these guidelines (August 1997) are included in this paper. Users of the GSOPs have found them to be useful when developing company standard operating procedures. The GSOPs help ensure a professional approach, adherence to good statistical practice, and compliance with regulatory requirements. GSOPs are always developing and evolving.