TPA utilizes multiple automated data collection systems to manage the histopathology data generated during necropsy, histology, histopathologic evaluation and special pathology procedures. The NCTR provides automated data base systems for the collection, storage and management of the data including the Gross Pathology System (GPS) and Micropathology Data Collection System (MDCS). GPS is used for the collection of gross pathology data and MDCS is used for the collection and maintenance of the histopathology data results from the pathologist’s slide evaluation for individual animals for all studies conducted at the NCTR.
All aspects of the histopathology data collection in GPS and MDCS are conducted in accordance with established SOPs and within the guidance of the applicable GLPs. TPA ensures all information in GPS and MDCS are up to date and maintains all study data relative to each animal on each study. TPA’s Information Specialist and Data Technicians have over 30 years cumulative experience in data collection and management using the GPS and MDCS.
An off the shelf software system, Pristima, was purchased by the NCTR to replace GPS and MDCS. TPA personnel are fully trained in the use of Pristima for data collection of all histopathology data. The Pristima suite includes multiple modules and functionality that will facilitate the pathology data management including the necropsy module, clinical pathology module, histopathology module and reports module when implemented.
TPA’s staff have developed extensive manuals of Standard Operating Procedures (SOPs) that provide written guidelines that must be followed to ensure consistency of technical procedures. The SOPs ensure the quality and integrity of the histopathology data and clearly and concisely detail all procedures performed in the pathology laboratory. TPA personnel adhere to these detailed SOPs to ensure performance, results and reports are accurate and complete, as well as properly documented and maintained.
TPA maintains archive services for all study materials, i.e., pathology specimens (residual wet tissues, tissue blocks, glass slides, frozen tissues, etc.), electronic data including clinical pathology data and digital images. The TPA Archivist, Information Specialist and Data Services technicians maintain controlled access to the archive study materials and provide a system to catalog and maintain study materials and ensure all study data is securely archived with best data quality and integrity practices and when applicable, in accordance with GLP compliance.