Morton Daniel, Sellers Rani S, Barale-Thomas Erio, Bolon Brad, George Catherine, Hardisty Jerry F, Irizarry Armando, McKay Jennifer S, Odin Marielle, Teranishi Munehiro
Pfizer Inc, Groton, Connecticut, USA.
Toxicol Pathol. 2010 Dec;38(7):1118-27. doi: 10.1177/0192623310383991. Epub 2010 Oct 5.
Pathology peer review verifies and improves the accuracy and quality of pathology diagnoses and interpretations. Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies. For pathology peer review conducted before study completion, the peer-review pathologist reviews sufficient slides and pathology data to assist the study pathologist in refining pathology diagnoses and interpretations. Materials to be reviewed are selected by the peer-review pathologist. Consultations with additional experts or a formal (documented) pathology working group may be used to resolve discrepancies. The study pathologist is solely responsible for the content of the final pathology data and report, makes changes resulting from peer-review discussions, initiates the audit trail for microscopic observations after all changes resulting from peer-review have been made, and signs the final pathologist's report. The peer-review pathologist creates a signed peer-review memo describing the peer-review process and confirming that the study pathologist's report accurately and appropriately reflects the pathology data. The study pathologist also may sign a statement of consensus. It is not necessary to archive working notes created during the peer-review process.
病理学同行评审可核实并提高病理学诊断及解读的准确性和质量。当重要的风险评估或商业决策基于非临床研究时，建议进行病理学同行评审。对于在研究完成前进行的病理学同行评审，同行评审病理学家会审查足够数量的玻片和病理学数据，以协助研究病理学家完善病理学诊断及解读。待审查的材料由同行评审病理学家选定。可通过与其他专家进行咨询或组建正式（有记录）的病理学工作组来解决分歧。研究病理学家对最终病理学数据和报告的内容负全责，根据同行评审讨论结果进行修改，在完成同行评审导致的所有修改后启动显微镜观察的审计追踪，并签署最终病理学家报告。同行评审病理学家会撰写一份有签名的同行评审备忘录，描述同行评审过程，并确认研究病理学家的报告准确且恰当地反映了病理学数据。研究病理学家也可签署一份共识声明。无需存档同行评审过程中产生的工作笔记。
