TY - JOUR
T1 - Society of Toxicologic Pathology Position Paper on Pathology Image Data
T2 - Compliance with 21 CFR Parts 58 and 11
AU - Tuomari, Darrell L.
AU - Kemp, Ramon K.
AU - Sellers, Rani
AU - Yarrington, John T.
AU - Geoly, Frank J.
AU - Fouillet, Xavier L.M.
AU - Dybdal, Noel
AU - Perry, Rick
N1 - Funding Information:
The recommendations in this paper are endorsed and supported by the American College of Veterinary Pathologists, and the British Society of Toxicological Pathologists.
PY - 2007/4
Y1 - 2007/4
N2 - The Society of Toxicologic Pathology (STP) has developed the following recommendations for the use of pathology images in compliance with the Code of Federal Regulations (CFR), Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures). These recommendations include: (1) based on current technologies and practices, pathology images (printed, electronic, or digital) used for data generation (e.g., to make a diagnosis or for morphometric analysis) are raw data that must be authenticated and archived; (2) authentication of an image may be done either by initialing and dating a print of the image or by specifically annotating the electronic image file in compliance with Part 11 regulations; (3) images used for raw data are subject to GLP procedures and controls in order to ensure data integrity including written Standard Operating Procedures, testing/validation of equipment, training of personnel, etc.; (4) validation and/or performance qualification of imaging systems used to support GLP studies must be documented and any exceptions to full validation/qualification must be described in the GLP Compliance Statement for the study; (5) images that are not used for data generation are illustrative images, are not raw data, and generally do not have to be archived; 6) illustrative images should not be used to re-evaluate or supersede the pathologist’s diagnosis.
AB - The Society of Toxicologic Pathology (STP) has developed the following recommendations for the use of pathology images in compliance with the Code of Federal Regulations (CFR), Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures). These recommendations include: (1) based on current technologies and practices, pathology images (printed, electronic, or digital) used for data generation (e.g., to make a diagnosis or for morphometric analysis) are raw data that must be authenticated and archived; (2) authentication of an image may be done either by initialing and dating a print of the image or by specifically annotating the electronic image file in compliance with Part 11 regulations; (3) images used for raw data are subject to GLP procedures and controls in order to ensure data integrity including written Standard Operating Procedures, testing/validation of equipment, training of personnel, etc.; (4) validation and/or performance qualification of imaging systems used to support GLP studies must be documented and any exceptions to full validation/qualification must be described in the GLP Compliance Statement for the study; (5) images that are not used for data generation are illustrative images, are not raw data, and generally do not have to be archived; 6) illustrative images should not be used to re-evaluate or supersede the pathologist’s diagnosis.
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U2 - 10.1080/01926230701284509
DO - 10.1080/01926230701284509
M3 - Article
C2 - 17474067
AN - SCOPUS:34250860116
SN - 0192-6233
VL - 35
SP - 450
EP - 455
JO - Toxicologic pathology
JF - Toxicologic pathology
IS - 3
ER -