A GLP-compliant Peer review (Part 1)

INTRODUCTION

The histopathological assessment of tissue samples is a key component of GLP-compliant toxicology studies (referred to as GLP studies). The histopathological assessment includes an initial read of tissue slides by the study pathologist and may include a subsequent review (referred to as pathology peer review) by a second, or peer-review pathologist. Pathology peer-review can be particularly useful in situations where unique or unexpected findings are noted or when the peer-review pathologist has a particular expertise with a class of compounds. Also, the peer review process can be part of a well defined workflow in order to Guarantee the quality and consistency of regular histopathological readings.

THE CONTEMPORANEOUS oR PROSPECTIVE PEER REVIEW

One of the most common types of peer-review is the classical contemporaneous peer review. This review occurs before the finalization of the pathology report eg. before signature and date. When pathology peer review occurs prospectively, the study pathologist should complete the analysis of all slides and prepare a draft pathology report.

THE RETROSPECTIVE PEER REVIEW

A pathology peer review that occurs after finalization of the pathology report is considered retrospective peer review. When pathology peer review occurs retrospectively, the study pathologist should document any changes to the conclusions of the study that result from the retrospective peer-review process in an amendment to the final pathology report. This is the type of peer-review which is conducted during due diligence