Good Statistical Practice in Clinical Research: Guideline Standard Operating Procedures

Abstract

Statisticians in the Pharmaceutical Industry (PSI) is a professional organization founded in 1977. One of the key objectives of PSI is to promote professional standards of statistics in matters pertinent to the pharmaceutical industry. During the period May 1990 to September 1991, the PSI Professional Standards Working Party developed a set of 11 guideline standard operating procedures. The objectives in doing this were to raise awareness of good statistical practice, encourage adherence to it, and provide guidance in the preparation of standard operating procedures within organizations represented by the membership. The 11 guideline standard operating procedures are presented here. They form a sound basis from which to develop standard operating procedures specific to the needs of individual organizations, and will be of benefit to professionals in many areas of clinical research.

Keywords

Good statistical practice Standard operating procedures Guidelines

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References

Guideline for The Format and Content of the Clinical and Statistical Sections of New Drug Applications. US Department of Health and Human Services. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research; July 1988.

CPMP Working Party on Efficacy of Medicinal Products; Note for Guidance; Good Clinical Practice for Trials on Medicinal Products in the European Community. Brussels, Belgium: Commission of the European Communities; July 1990; 111/396/88-EN Final.