1 Society of Toxicologic Pathology Position Paper Best Practices for Reporting Pathology Interpretations within GLP Toxicology Studies

The study pathologist provides specialized expertise to the interpretation of the toxicity and safety of pharmaceuticals, biological agents, human and animal food additives, environmental and industrial chemicals, and medical devices in animal studies. The study pathologist’s findings and conclusions must be accurately and completely reflected in the study report. The pathology findings also must be integrated with other study data to provide a comprehensive discussion of toxicity and/or pharmacology of a chemical, device, or material and the relationship of toxicity to exposure. The Society of Toxicologic Pathology (STP) offers the following recommendations to help pathologists, study directors, other study personnel, management, and sponsors guarantee the quality and reliability of pathology data and interpretations incorporated within animal toxicology studies. In this paper, “pathologist ” refers to both anatomic and clinical pathologists unless otherwise specified. The Study Pathologist Should Review and Contribute to the Study Protocol Whenever possible, the study pathologist(s) should review and/or contribute to the generation of the study protocol and should ensure that the pathology components of the protocol reflect appropriate scientific methods and current standards of pathology practice. If the stud