Document Detail


Regulatory Forum Opinion Piece*: Clarification and Simplification of the Pathology Peer Review Documentation Process.
MedLine Citation:
PMID:  24357643     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The transparency and documentation of the peer review process have been discussed recently. Our position is that transparency is best achieved when peer review is a collaborative process, in which both parties are open-minded but both also realize that the study pathologist retains complete control over the findings (raw data) and over the content of the pathology report. For these reasons, we believe that histopathology raw data should be defined as the observations made by the study pathologist (printed and/or electronic formats) rather than as the tissue slides recommended by the Organisation for Economic Co-operation and Development (OECD). Also, because the study pathologist retains control over the histopathology raw data, any notes or tabulations of findings by the study pathologist and peer review pathologist during the peer review are interim notes and should not be included as an appendix to the pathology report though they may be retained if desired, as currently recommended. Because the histopathology raw data have not been created until completion of the peer review, the performance of a peer review should be documented in the study report, as currently recommended, but that it not be a GLP-compliant process.
Authors:
Michael J Tomlinson; Joel R Leininger
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-12-19
Journal Detail:
Title:  Toxicologic pathology     Volume:  -     ISSN:  1533-1601     ISO Abbreviation:  Toxicol Pathol     Publication Date:  2013 Dec 
Date Detail:
Created Date:  2013-12-20     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7905907     Medline TA:  Toxicol Pathol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
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