{"created":"2023-07-27T06:52:36.091409+00:00","id":46623,"links":{},"metadata":{"_buckets":{"deposit":"f7c4cd3c-3075-4bb2-87d9-083323988230"},"_deposit":{"created_by":18,"id":"46623","owners":[18],"pid":{"revision_id":0,"type":"depid","value":"46623"},"status":"published"},"_oai":{"id":"oai:kanazawa-u.repo.nii.ac.jp:00046623","sets":["2812:2813:2815"]},"author_link":["81145","81144"],"item_9_biblio_info_8":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2019-06-06","bibliographicIssueDateType":"Issued"},"bibliographicPageStart":"4p.","bibliographicVolumeNumber":"2015-04-01 - 2019-03-31","bibliographic_titles":[{"bibliographic_title":"平成30(2018)年度 科学研究費補助金 挑戦的萌芽研究 研究成果報告書"},{"bibliographic_title":"2018 Fiscal Year Final Research Report","bibliographic_titleLang":"en"}]}]},"item_9_creator_33":{"attribute_name":"著者別表示","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Takahara, Sizuko"}],"nameIdentifiers":[{"nameIdentifier":"81145","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"60446755","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://kaken.nii.ac.jp/ja/search/?qm=60446755"}]}]},"item_9_description_21":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"当初の計画では、①プロトコールテンプレート作成、②標準CRF作成、③治験データ管理システムへのCDISC/SDTM出力管理機能搭載、④検証と普及が主な柱であり、①②については原案作成が完了した。③については当初予定していたシステムへの機能上乗せでは困難であると判断し、既にCDISC対応しているEDCシステムを利用し、検証を実施した。困難であると判断したのが本研究4年目に入ってからであり、現段階では実試験での検証がほぼ終わった状況である。今後、①②の再整備と③の整理、④の普及に向けての残作業を行う予定である。","subitem_description_type":"Abstract"},{"subitem_description":"We had made a protocol template and standard CRF (Case Report Form) model. And we planned to add CDISC/SDTM output function to a system, but gave it up because it is so difficult. We changed a plan to already use the EDC (Electric Data Capture) system with the function, we succeeded in test that is a real investigator initiated trials. ","subitem_description_type":"Abstract"}]},"item_9_description_22":{"attribute_name":"内容記述","attribute_value_mlt":[{"subitem_description":"研究課題/領域番号:15K15250, 研究期間(年度):2015-04-01 - 2019-03-31","subitem_description_type":"Other"},{"subitem_description":"出典：研究課題「アカデミアにおける臨床研究データ管理のCDISC準拠体制モデルの構築」課題番号15K15250\n（KAKEN：科学研究費助成事業データベース（国立情報学研究所）） \n（https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-15K15250/15K15250seika/）を加工して作成","subitem_description_type":"Other"}]},"item_9_identifier_registration":{"attribute_name":"ID登録","attribute_value_mlt":[{"subitem_identifier_reg_text":"10.24517/00052955","subitem_identifier_reg_type":"JaLC"}]},"item_9_publisher_17":{"attribute_name":"公開者","attribute_value_mlt":[{"subitem_publisher":"金沢大学附属病院先端医療開発センター"}]},"item_9_relation_28":{"attribute_name":"関連URI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_text":"https://kaken.nii.ac.jp/search/?qm=60446755"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://kaken.nii.ac.jp/search/?qm=60446755","subitem_relation_type_select":"URI"}},{"subitem_relation_name":[{"subitem_relation_name_text":"https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-15K15250/"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-15K15250/","subitem_relation_type_select":"URI"}},{"subitem_relation_name":[{"subitem_relation_name_text":"https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-15K15250/15K15250seika/"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://kaken.nii.ac.jp/report/KAKENHI-PROJECT-15K15250/15K15250seika/","subitem_relation_type_select":"URI"}}]},"item_9_version_type_25":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_ab4af688f83e57aa","subitem_version_type":"AM"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"高原, 志津子"}],"nameIdentifiers":[{"nameIdentifier":"81144","nameIdentifierScheme":"WEKO"},{"nameIdentifier":"60446755","nameIdentifierScheme":"e-Rad","nameIdentifierURI":"https://kaken.nii.ac.jp/ja/search/?qm=60446755"}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2020-04-24"}],"displaytype":"detail","filename":"HO-PR-TAKAHARA-S-kaken 2019-4p.pdf","filesize":[{"value":"72.8 kB"}],"format":"application/pdf","licensetype":"license_11","mimetype":"application/pdf","url":{"label":"HO-PR-TAKAHARA-S-kaken 2019-4p.pdf","url":"https://kanazawa-u.repo.nii.ac.jp/record/46623/files/HO-PR-TAKAHARA-S-kaken 2019-4p.pdf"},"version_id":"9847436f-ec06-402a-8f9a-c1d217b8225c"}]},"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":"research report","resourceuri":"http://purl.org/coar/resource_type/c_18ws"}]},"item_title":"アカデミアにおける臨床研究データ管理のCDISC準拠体制モデルの構築","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"アカデミアにおける臨床研究データ管理のCDISC準拠体制モデルの構築"},{"subitem_title":"A Model of Clinical Data Management based on CDISC for Academia","subitem_title_language":"en"}]},"item_type_id":"9","owner":"18","path":["2815"],"pubdate":{"attribute_name":"公開日","attribute_value":"2020-04-24"},"publish_date":"2020-04-24","publish_status":"0","recid":"46623","relation_version_is_last":true,"title":["アカデミアにおける臨床研究データ管理のCDISC準拠体制モデルの構築"],"weko_creator_id":"18","weko_shared_id":-1},"updated":"2024-07-01T05:29:17.956110+00:00"}