{"id":87,"date":"2017-11-27T16:12:00","date_gmt":"2017-11-27T21:12:00","guid":{"rendered":""},"modified":"2018-10-26T11:00:46","modified_gmt":"2018-10-26T15:00:46","slug":"ata-58-session-summary-j-2-japanese-english-translation-of-clinical-trial-documents","status":"publish","type":"post","link":"https:\/\/www.ata-divisions.org\/JLD\/2017\/11\/27\/ata-58-session-summary-j-2-japanese-english-translation-of-clinical-trial-documents\/","title":{"rendered":"ATA 58 Session Summary – J-2: Japanese > English Translation of Clinical Trial Documents"},"content":{"rendered":"
\n
Japanese > English Translation of Clinical Trial Documents<\/span><\/strong><\/div>\n
Presented by Matthew Schlect, <\/strong>PhD<\/span><\/div>\n
ATA 58th Annual Conference Session J-2
Thursday, October 26, 3:30pm-4:30pm<\/span><\/div>\n
Summary<\/strong> (Contributed by Kazumasa Aoyama):<\/span><\/div>\n

In the second JDL session of the conference, we had an opportunity to hear and learn from Dr. Matthew Schlect about Japanese to English translation of clinical trial documents. Dr. Schlect was a researcher in chemistry and life sciences for 20 years before he started his freelance work and has been a freelance translator, editor and writer for 15 years. He is currently a member of the leadership council for ATA’s Science and Technology Division.<\/span>
As a part of his introduction, Japanese medical language was discussed:<\/span><\/p>\n

    \n
  1. Japanese medical terms are often compounds of familiar elements (e.g. \u7cd6\u5c3f\u75c5), while many English medical terms came from Latin and Greek (e.g. diabetes).<\/span><\/li>\n
  2. Japanese has many medical terms borrowed from English and German (e.g. \u30ab\u30c6\u30fc\u30c6\u30eb (catheter) and \u30be\u30f3\u30c7 (Sonde (German), probe (English))).<\/span><\/li>\n
  3. Japan has a long tradition of Oriental Medicine (\u6f22\u65b9), and Western science and medicine were introduced to Japan from Germany through Dutch merchants in the Meiji Era (1868-1912)<\/span><\/li>\n<\/ol>\n

    Then the following were presented:<\/span><\/p>\n

      \n
    1. Clinical trials (what, who and why)<\/span><\/li>\n
    2. Types of clinical trials (Phase I (\u7b2c\uff29\u76f8\u8a66\u9a13), Phase II (\u7b2c\u2161\u76f8\u8a66\u9a13), etc.)<\/span><\/li>\n
    3. Clinical design (Some key terms were discussed.) (blinding (\u76f2\u691c\u5316), endpoint (\u8a55\u4fa1\u9805\u76ee), etc.)<\/span><\/li>\n
    4. Those who are involved in clinical trials (principal investigator (\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b), sponsor (\u6cbb\u9a13\u4f9d\u983c\u8005), etc.)<\/span><\/li>\n
    5. Clinical trial facilities (study center (\u6cbb\u9a13\u5b9f\u65bd\u533b\u7642\u6a5f\u95a2), testing facilities (\u8a66\u9a13\u5b9f\u65bd\u65bd\u8a2d), etc.)<\/span><\/li>\n
    6. Clinical trial documents and formats with examples.<\/span>\n
        \n
      • Clinical trial protocol (\u6cbb\u9a13\u5b9f\u65bd\u8a08\u753b\u66f8)<\/span><\/li>\n
      • Investigator’s Brochure (IB) (\u6cbb\u9a13\u85ac\u6982\u8981\u66f8)<\/span><\/li>\n
      • Clinical trial agreement\/contract (\u6cbb\u9a13\u5b9f\u65bd\u5951\u7d04\u66f8)<\/span><\/li>\n
      • Clinical trial report (\u6cbb\u9a13\u5831\u544a\u66f8)<\/span><\/li>\n
      • Standard Operating Procedures (SOPs) (\u6a19\u6e96\u696d\u52d9\u624b\u9806\u66f8)<\/span><\/li>\n
      • Informed Consent Forms (ICF) (\u540c\u610f\u8aac\u660e\u6587\u66f8)<\/span><\/li>\n
      • Case Report Form (CRF) (\u75c7\u4f8b\u5831\u544a\u66f8)<\/span><\/li>\n
      • Institutional Review Board (IRB) Report (\u6cbb\u9a13\u5be9\u67fb\u59d4\u54e1\u4f1a\u5831\u544a\u66f8)<\/span><\/li>\n
      • Medical Journal Articles (\u533b\u5b66\u96d1\u8a8c\u306e\u8a18\u4e8b)<\/span><\/li>\n<\/ul>\n<\/li>\n<\/ol>\n

        Following the discussion above, terminology \u2013 standardized clinical nomenclature (MedDRA) and Common Terminology Criteria for Adverse Events (CTCAE), and drug\/disease\/procedure names were discussed followed by the process of translation of clinical trials. Dr. Schlect pointed out that there are three steps in the translation process: research, translation, and validation:<\/span><\/p>\n

          \n
        1. Research:
          Skim through title, abstract, key words, unfamiliar terms.
          Research unfamiliar topics in the source & target language
          MedDra
              CTCAE (https:\/\/evs.nci.nih.gov\/ftp1\/CTCAE\/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf)
              Clinical trial databases
                 WHO International Clinical Trials Registry (https:\/\/www.who.int\/ictrp\/en\/)
                  US National Library of Medicine Clinical Trials Registry (https:\/\/www.clinicaltrials.gov\/ct2\/home)
                  EU Clinical Trials Register (https:\/\/www.clinicaltrialsregister.eu\/)
                  \u81e8\u5e8a\u8a66\u9a13\u306e\u691c\u7d22 (https:\/\/upload.umin.ac.jp\/cgi-open-bin\/ctr\/index.cgi?function=02)<\/span><\/li>\n
        2. Translation<\/span><\/li>\n
        3. Validation: Validate that key translation terms\/phrases are found “in the wild” in texts written by native authors.<\/span><\/li>\n<\/ol>\n

          At the conclusion, Dr. Schlect told us: To succeed at clinical translation,<\/span><\/p>\n

            \n
          • Being a doctor or nurse is not a requirement.<\/span><\/li>\n
          • Do need careful research, translation, and validation<\/span><\/li>\n
          • Experience with clinical content will facilitate professional clinical document translations<\/span><\/li>\n
          • Controlled language (MeDRA, CTCAE) seems tedious, but standardization is necessary<\/span><\/li>\n
          • Use the extensive resource available<\/span><\/li>\n<\/ul>\n

            He also presented useful English medical resources, Japanese to English resources, and clinical terminology resources. Below are some of the resources:<\/span><\/p>\n

              \n
            • NIH PubMed (https:\/\/www.ncbi.nlm.nih.gov\/pubmed)<\/span><\/li>\n
            • Sangyo \u6012\u6d9b\u306e\u8f9e\u66f8\uff08\u7ffb\u8a33\u4f8b\u8f9e\u66f8\uff09(https:\/\/www.sangyo-honyaku.jp\/dictionaries)<\/span><\/li>\n
            • \u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u8f9e\u66f8\u30aa\u30f3\u30e9\u30a4\u30f3\u30b5\u30fc\u30d3\u30b9 (https:\/\/lsd-project.jp\/cgi-bin\/lsdproj\/ejlookup04.pl)<\/span><\/li>\n
            • CDISC Clinical Research Glossary (EN\/JA) (https:\/\/www.tri-kobe.org\/cdisc\/glossary\/glossary.php<\/span><\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

              Japanese > English Translation of Clinical Trial Documents Presented by Matthew Schlect, PhD ATA 58th Annual Conference Session J-2Thursday, October 26, 3:30pm-4:30pm Summary (Contributed by Kazumasa Aoyama): In the second JDL session of the conference, we had an opportunity to hear and learn from Dr. Matthew Schlect about Japanese to English translation of clinical trial documents. Dr. […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[11,22],"tags":[],"_links":{"self":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/87"}],"collection":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/comments?post=87"}],"version-history":[{"count":1,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/87\/revisions"}],"predecessor-version":[{"id":193,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/87\/revisions\/193"}],"wp:attachment":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/media?parent=87"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/categories?post=87"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/tags?post=87"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}