{"created":"2023-05-15T14:35:52.353121+00:00","id":46155,"links":{},"metadata":{"_buckets":{"deposit":"8627bc4c-0542-4f8d-a4b8-8f6e1a7355a1"},"_deposit":{"created_by":1,"id":"46155","owners":[1],"pid":{"revision_id":0,"type":"depid","value":"46155"},"status":"published"},"_oai":{"id":"oai:repo.qst.go.jp:00046155","sets":["1"]},"author_link":["459559","459557","459558","459548","459551","459541","459554","459549","459556","459540","459544","459550","459543","459552","459553","459555","459545","459547","459542","459546"],"item_8_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2011-07","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"1","bibliographicPageEnd":"29","bibliographicPageStart":"5","bibliographicVolumeNumber":"39","bibliographic_titles":[{"bibliographic_title":"臨床評価"}]}]},"item_8_description_5":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"?．背景\n治験の実施においては，被験者に健康被害をもたらさないことが最も重要であり，そのための安全対策の充実に向けた努力がなされている．しかしそれにも係わらず健康被害が発生してしまうことを想定しなければならず，そうなった場合の対策の強化は，被験者の保護をより充実させるために必須である．日本の「医薬品の臨床試験の実施の基準に関する省令」1）やその運用通知2）に示される健康被害補償の考え方は，ICH-GCP3）にも十分既定されず，世界的にも十分な制度を定めている国は少ない．日本の製薬企業の自主ルールとして医薬品企業法務研究会が「被験者の健康被害補償に関するガイドライン」4，5）（以下「医法研ガイドライン」）を公表しているが，その運用状況についての系統的・包括的な調査・分析は行われ\nてこなかった．また，ガイドラインの内容をいかに被験者に情報提供するかについても合意形成は十分ではない．\n?．目的\n健康被害に対する補償対応の実態を明らかにし，その結果に基づき，被験者に対する情報提供\nのあり方について提言を行うことを目的とする．\n?．方法\n国内外における被験者健康被害補償の制度や考え方につき文献調査を行った上，下記の4 つの調査対象につき，治験における健康被害補償について実態調査および／または意識調査を，web アンケートまたは質問紙票により行い（回答はすべて無記名），著者らにおいて討議を行った．","subitem_description_type":"Abstract"}]},"item_8_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0300-3051","subitem_source_identifier_type":"ISSN"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"渡邉, 裕司"}],"nameIdentifiers":[{"nameIdentifier":"459540","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"景山, 茂"}],"nameIdentifiers":[{"nameIdentifier":"459541","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"楠岡, 英雄"}],"nameIdentifiers":[{"nameIdentifier":"459542","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"小野, 俊介"}],"nameIdentifiers":[{"nameIdentifier":"459543","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"斉藤, 和幸"}],"nameIdentifiers":[{"nameIdentifier":"459544","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"磯部, 哲"}],"nameIdentifiers":[{"nameIdentifier":"459545","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"掛江, 直子"}],"nameIdentifiers":[{"nameIdentifier":"459546","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原, 千絵子"}],"nameIdentifiers":[{"nameIdentifier":"459547","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"作広, 卓哉"}],"nameIdentifiers":[{"nameIdentifier":"459548","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"青木, 寛"}],"nameIdentifiers":[{"nameIdentifier":"459549","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"辻出, 清和"}],"nameIdentifiers":[{"nameIdentifier":"459550","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"鍋岡, 勇造"}],"nameIdentifiers":[{"nameIdentifier":"459551","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"森下, 典子"}],"nameIdentifiers":[{"nameIdentifier":"459552","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"鈴木, 千恵子"}],"nameIdentifiers":[{"nameIdentifier":"459553","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"可知, 茂男"}],"nameIdentifiers":[{"nameIdentifier":"459554","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"竹原, 健二"}],"nameIdentifiers":[{"nameIdentifier":"459555","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"辻本, 好子"}],"nameIdentifiers":[{"nameIdentifier":"459556","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"近藤, 恵美子"}],"nameIdentifiers":[{"nameIdentifier":"459557","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"小森, 有希子"}],"nameIdentifiers":[{"nameIdentifier":"459558","nameIdentifierScheme":"WEKO"}]},{"creatorNames":[{"creatorName":"栗原 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