{"created":"2023-07-27T06:30:19.678833+00:00","id":15303,"links":{},"metadata":{"_buckets":{"deposit":"8f51376b-c356-4f92-8189-ac6f328986b5"},"_deposit":{"created_by":3,"id":"15303","owners":[3],"pid":{"revision_id":0,"type":"depid","value":"15303"},"status":"published"},"_oai":{"id":"oai:kanazawa-u.repo.nii.ac.jp:00015303","sets":["1132:1133:1135"]},"author_link":["706","22059","27730"],"item_4_biblio_info_8":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2008-05-01","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"3","bibliographicPageEnd":"104","bibliographicPageStart":"99","bibliographicVolumeNumber":"39","bibliographic_titles":[{"bibliographic_title":"臨床薬理 = Japanese journal of clinical pharmacology"}]}]},"item_4_description_21":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"Protocols and case report forms are different among clinical trials, however adverse events (AEs) occur in every trial and need to be assessed in the same way. Therefore, we conducted a survey to examine the actual condition of the information of AEs. We surveyed choices and criterions of items for AEs of 59 trials which were performed in Kanazawa University Hospital. As a result of the survey, it became clear that choices currently used for each item were varied and different in each trial. Criteria of severity and outcome were also varied ; there were even contradicting criteria among trials. There were also contradictory judgments of adverse drug reactions (ADRs), and the definition of \"Probably not\" expressed as an ADR differed. Moreover, in these trials, the criteria for \"Probably not\" was not markedly different. From these results, it was suggested that current the collection and assessment of the information of AEs were different in each trial and thereby assessments could also be different. Pharmaceutical companies, regulatory agenceis, and medical institutions should be in discussion to determine standardization of the expression of choices and criterions of AEs.","subitem_description_type":"Abstract"}]},"item_4_publisher_17":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics"}]},"item_4_relation_12":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.3999/jscpt.39.99","subitem_relation_type_select":"DOI"}}]},"item_4_relation_28":{"attribute_name":"関連URI","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"http://www.jscpt.jp/","subitem_relation_type_select":"URI"}},{"subitem_relation_type_id":{"subitem_relation_type_id_text":"http://www.jstage.jst.go.jp/article/jscpt/39/3/39_99/_article/-char/ja","subitem_relation_type_select":"URI"}}]},"item_4_rights_23":{"attribute_name":"権利","attribute_value_mlt":[{"subitem_rights":"Copyright (c) 2009 日本臨床薬理学会"}]},"item_4_source_id_11":{"attribute_name":"NCID","attribute_value_mlt":[{"subitem_source_identifier":"AN0025404X","subitem_source_identifier_type":"NCID"}]},"item_4_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0388-1601","subitem_source_identifier_type":"ISSN"}]},"item_4_version_type_25":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"吉冨, 克則"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"古川, 裕之"}],"nameIdentifiers":[{},{}]},{"creatorNames":[{"creatorName":"宮本, 謙一"}],"nameIdentifiers":[{},{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2017-10-04"}],"displaytype":"detail","filename":"PH-PR-MIYAMOTO-K-99.pdf","filesize":[{"value":"237.7 kB"}],"format":"application/pdf","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"PH-PR-MIYAMOTO-K-99.pdf","url":"https://kanazawa-u.repo.nii.ac.jp/record/15303/files/PH-PR-MIYAMOTO-K-99.pdf"},"version_id":"b46d5c96-3e01-472d-98b8-325f07afa369"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"jpn"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"臨床試験において収集される有害事象情報の実態調査","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"臨床試験において収集される有害事象情報の実態調査"},{"subitem_title":"Survey of the information of adverse events in clinical trials","subitem_title_language":"en"}]},"item_type_id":"4","owner":"3","path":["1135"],"pubdate":{"attribute_name":"公開日","attribute_value":"2017-10-04"},"publish_date":"2017-10-04","publish_status":"0","recid":"15303","relation_version_is_last":true,"title":["臨床試験において収集される有害事象情報の実態調査"],"weko_creator_id":"3","weko_shared_id":-1},"updated":"2023-07-28T00:34:37.556141+00:00"}