In 2017, EPL has conducted 189 pathology peer reviews, including 28 peer reviews on 2-year carcinogenicity studies and transgenic rasH2 mouse 26-week carcinogenicity projects. Each project requires set up of our unique peer review system ahead of the actual peer review conduct.
Our PQA software program is a computerized pathology peer review procedure developed at EPL. This system ensures that the accuracy of the data is maintained during the entire review process and that comparison between the preliminary histopathology data from the laboratory and the pathology quality assurance audit can be made rapidly. Differences can be easily identified and resolved by the study pathologist and reviewing pathologist, thus allowing the laboratory to complete the draft study report in a timely manner. As another key benefit of the PQA system, in areas of the globe, such as Japan and China, where regulators require documentation of all slides reviewed, PQA software produces a ready-made report to satisfy this requirement.
In order to properly set up the peer review system, EPL requests the following data and information as soon as it is available, preferably at least 1 week prior to the start of the peer review:
- An ASCII text version of the Individual Animal Data (pathology data only)
- A printable version of the Individual Animal Data
- A copy of the summary tables for the pathology data
- A copy of the narrative and/or a list of the potential target tissues
- A copy of the tissue blocking list (order tissues appear on the slides)
- A copy of the protocol and all amendments issued to date
The above information covers the items that will allow us to set up the pathology peer review and maintain the scheduling. We’re always happy to answer questions regarding any of these required items.
EPL’s peer review system offers many benefits, allowing for an efficient pathology peer review process and high quality pathology data. Most peer reviews can be conducted and, more importantly, completed while the peer review pathologist is at the site of the study pathologist.