The OECD issued the "Guidelines for Peer Review of Toxic Pathology under GLP Conditions" in September 2014. The guidelines clearly stipulate the planning, implementation, and reporting requirements for peer review of toxic pathology under GLP conditions.
Peer review of toxic pathology is one of the important means to ensure the correct evaluation of test results in non-clinical trials. Correct implementation of peer review can ensure that the test results are true and reliable, and the test process can be traced.
The main requirements of the guidelines include:
1. The peer review plan for toxic pathology should be included in the trial protocol or protocol amendment.
2. The re-examined specimens and re-examined documents should be recorded, and the peer review process should be detailed and traceable.
3. Procedures should be established for handling disagreements between peer-reviewed pathologists and experimental pathologists.
Four. After peer review, if there is an important change in the diagnosis result of the experimental pathologist, it should be explained in the pathology report.
5. The name, qualifications and unit of the peer-reviewed pathologist should be specified in the pathology report.