Histopathology Peer Review in Nonclinical Toxicology Studies
This guidance provides recommendations for managing and conducting histopathology peer review in nonclinical toxicology studies under GLP regulations. It clarifies documentation practices and requirements for pathology peer review processes, which involve review of a study pathologist's diagnoses by peer-review pathologist(s) or pathology working groups (PWG).
What You Need to Know? 👇
What is pathology peer review in nonclinical toxicology studies?
Pathology peer review is a process where diagnoses and interpretations from a study pathologist are reviewed by one or more peer-review pathologists or pathology working groups to ensure quality and accuracy of histopathological assessments in GLP toxicology studies.
When should pathology peer review be conducted during a study?
Pathology peer review can occur either contemporaneously (before finalization of the study pathologist’s report) or retrospectively (after finalization). Contemporaneous review requires a written narrative before peer review, while retrospective review requires amendments to document any changes.
What qualifications should a peer-review pathologist have for medical device studies?
A peer-review pathologist should have appropriate education, training, and experience in histological assessments. Beneficial qualifications include experience with the route of administration, test article contact type, study species, duration, design, and knowledge of the test article’s mechanism of action.
How should pathology peer review be documented in GLP studies?
Pathology peer review must be well-documented with signed and dated peer-review statements included in the final study report. Documentation should include reviewer identity, review dates, compliance status, tissues examined, format used, terminology agreement, and any data utilized during review.
Can pathology peer review be conducted at non-GLP compliant facilities?
Yes, pathology peer review can be conducted at non-GLP compliant sites if study integrity is protected. However, this must be recorded in the study protocol and final report, with peer-review pathologist qualifications, training, and affiliations documented and retained at the testing facility.
How are disagreements between study and peer-review pathologists resolved?
Disagreements should be addressed using transparent, unbiased processes described in written procedures (SOPs, protocols, or amendments). Resolution may involve consultation with additional experienced pathologists or pathology working groups, with all communications and consensus decisions properly documented and retained.
What You Need to Do 👇
Recommended Actions
- Establish written procedures (SOPs) for pathology peer review process
- Ensure peer review pathologists have appropriate qualifications and training
- Document peer review in study protocol or amendment
- Implement measures to ensure independence and prevent undue influence
- Create templates for peer review statements including all required information
- Establish procedures for handling differences in interpretation
- Maintain comprehensive documentation of peer review process and communications
- Include signed peer review statements in final study reports
- Create process for amendments when retrospective changes are needed
- Establish record retention procedures for all peer review documentation
Key Considerations
Non-clinical testing
- Peer review can be conducted before finalization (contemporaneous) or after finalization (retrospective) of the study pathologist’s report
- Study pathologist must prepare written narrative of diagnoses before contemporaneous peer review
- Changes from retrospective review must be documented in amendments
- Peer review process must be included in study protocol or amendment
- Written procedures must guide the review process
- Peer review can be conducted at non-GLP sites if study integrity is protected
Other considerations
- Peer-review pathologist must have appropriate education, training and experience
- Peer review statement must be signed and dated, including specific required information
- Process must be transparent and free from undue influence
- Differences in interpretation must be addressed through documented procedures
- All communications regarding differences of opinion must be retained
- Final study report must include signed peer review statement
Relevant Guidances 🔗
- Immunological Testing for Medical Devices: Evaluation and Assessment of Adverse Effects
- Good Laboratory Practice (GLP) Requirements for Non-Clinical Laboratory Studies
- Use of Whole Slide Imaging in GLP Nonclinical Toxicology Studies
Related references and norms 📂
- 21 CFR Part 58: Good Laboratory Practice for Nonclinical Laboratory Studies
Original guidance
- Histopathology Peer Review in Nonclinical Toxicology Studies
- HTML / PDF
- Issue date: 2021-12-27
- Last changed date: 2024-10-01
- Status: FINAL
- Official FDA topics: Tobacco, Medical Devices, Food & Beverages, Pharmacology/Toxicology, Drugs, Animal & Veterinary, Biologics
- ReguVirta ID: cb8f1f9512ddf28d4bd043abe3f94b70