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监管论坛观点文章:病理学同行评审文件流程的澄清与简化

Regulatory forum opinion piece: Clarification and simplification of the pathology peer review documentation process.

作者信息

Tomlinson Michael J, Leininger Joel R

机构信息

1Nova Pathology, PC, Bellingham, Washington, USA.

出版信息

Toxicol Pathol. 2014;42(2):309-10. doi: 10.1177/0192623313517061. Epub 2013 Dec 19.

DOI:10.1177/0192623313517061
PMID:24357643
Abstract

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.

摘要

同行评审过程的透明度和文件记录问题近来已被讨论。我们的立场是,当同行评审是一个协作过程时,透明度能得到最佳实现,在此过程中,双方都应持开放态度,但同时也要认识到研究病理学家对研究结果(原始数据)以及病理报告内容保留完全控制权。基于这些原因,我们认为组织病理学原始数据应定义为研究病理学家所做的观察(打印和/或电子格式),而非经济合作与发展组织(OECD)所推荐的组织切片。此外,由于研究病理学家对组织病理学原始数据保留控制权,同行评审期间研究病理学家和同行评审病理学家所做的任何发现记录或列表都是临时记录,不应作为病理报告的附录包含在内,不过如有需要,可按当前建议予以保留。由于组织病理学原始数据在同行评审完成之前并未产生,同行评审的实施情况应按当前建议在研究报告中记录,但它并非一个符合GLP规范的过程。

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