Utilizing Whole Slide Images for the Primary Evaluation and Peer Review of a GLP-Compliant Rodent Toxicology Study. (August 2021)

• Record Type: Journal Article
• Authors: Jacobsen, Matt; Lewis, Arthur; Baily, James; Fraser, Alain; Rudmann, Dan; Ryan, Shane
• Is Part Of: Toxicologic pathology. Volume 49:Number 6(2021)
• Page Start: 1164
• Page End: 1173
• Publication Date: 2021-08
• Subjects: whole slide image -- peer review -- primary evaluation -- digital histopathology -- GLP validation -- regulatory toxicology study; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/01926233211017031
• Languages: English
• ISSNs: 0192-6233

Abstract

The approach undertaken to deliver a Good Laboratory Practice (GLP) validation of whole slide images (WSIs) and the associated workflow for the digital primary evaluation and peer review of a GLP-compliant rodent inhalation toxicity study is described. The contract research organization (CRO) undertook validation of the slide scanner, scanner software, and associated database software. This provided a GLP validated environment within the database software for the primary histopathologic evaluation using WSI and viewed with the database software web viewer. The CRO also validated a cloud-based digital pathology platform that supported the upload and transfer of WSI and metadata to a cache within the sponsor's local area network. The sponsor undertook a separate GLP validation of the same cloud-based digital pathology platform to cover the download and review of the WSI. The establishment of a fit-for-purpose GLP-compliant workflow for WSI and successful deployment for the digital primary evaluation and peer review of a large GLP toxicology study enabled flexibility in accelerated global working and potential future reuse of digitized data for advanced artificial intelligence and machine learning image analysis.