- Test Facility organisation and personnel (Sponsor/CRO/Sub-Contractor Responsibilities - Including IT Providers)
- Quality Assurance
- Equipment and computerized systems
- Test items, reference items and samples/specimens (including for Biologicals, GMOs, etc.)
- SOPs
- Management of the study
- Histopathology
- Archives Including E-Archives
- Monitoring Test Facility compliance by GLP CMAs