The Pathology Report, Peer Review, and Pathology Working Group

Abstract

The pathology report is the mechanism by which the important results of the pathology assessment are communicated to the interested parties, which range from study directors, sponsors, regulators, and investors. In this chapter, we review the structure of a pathology report and what should be expected to be in each section. The sections of a pathology report generally include a summary, description of methods, and results. The results section consists of a discussion on organ weights, macroscopic findings, and microscopic findings and should identify test article-related findings and address their significance. There is a review of terminology that is often used in pathology reports and which can be confusing to a non-pathologist. Interpretation of adversity is also discussed. The chapter expands on pathology reporting by discussing quality assessment of the pathology report through peer review and pathology working groups. The types of peer reviews and the methodology for performing them are presented as is a discussion on conducting a pathology working group.