The Basics of Raw Data in Pathology

Raw Data are defined in both the FDA’s 1987 final rule and OECD 2014 advisory documents.

Raw data may include photographs, microfilm, copies, computer printouts, magnetic media, worksheets, records, and notes or exact copies of the notes that are the result of original observations and activities and that are necessary for the reconstruction of the final study repot.

In Translational Pathology it is the pathology report which constitutes the raw data, but necropsy notes even handwritten are considered as raw data as well as they are mandatory to reconstruct the study.

The original glass slides are derived from a test system and are considered as the Specimen. Consequently, they should be archived as they are needed for the reconstruction of the study.

In general, illustrative or consulting images are not Considered raw data. when these images are used for regulatory submission or used to create the pathology report (morphometry), they should be authenticated and archived, Although they are not considered as raw data. A more in depth discussion can be found Under de digital pathology blog when images are originating from whole slide images.