{"_buckets": {"deposit": "efd3c0e7-d941-40c2-9ed1-da5ab5159281"}, "_deposit": {"id": "2002124", "owners": [1], "pid": {"revision_id": 0, "type": "depid", "value": "2002124"}, "status": "published"}, "_oai": {"id": "oai:nagoya.repo.nii.ac.jp:02002124", "sets": ["1646019880489"]}, "author_link": [], "control_number": "2002124", "item_1615768549627": {"attribute_name": "出版タイプ", "attribute_value_mlt": [{"subitem_version_resource": "http://purl.org/coar/version/c_970fb48d4fbd8a85", "subitem_version_type": "VoR"}]}, "item_1615768833594": {"attribute_name": "助成情報", "attribute_value_mlt": [{"subitem_award_numbers": {"subitem_award_number": "15K15250", "subitem_award_uri": "https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-15K15250/"}, "subitem_award_titles": [{"subitem_award_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_award_title_language": "ja"}], "subitem_funder_names": [{"subitem_funder_name": "日本学術振興会", "subitem_funder_name_language": "ja"}, {"subitem_funder_name": "Japan Society for the Promotion of Science", "subitem_funder_name_language": "en"}]}]}, "item_9_biblio_info_6": {"attribute_name": "書誌情報", "attribute_value_mlt": [{"bibliographicIssueDates": {"bibliographicIssueDate": "2022-02", "bibliographicIssueDateType": "Issued"}, "bibliographicIssueNumber": "1", "bibliographicPageEnd": "132", "bibliographicPageStart": "120", "bibliographicVolumeNumber": "84", "bibliographic_titles": [{"bibliographic_title": "Nagoya Journal of Medical Science", "bibliographic_titleLang": "en"}]}]}, "item_9_description_4": {"attribute_name": "内容記述", "attribute_value_mlt": [{"subitem_description": "Submitting data compliant with the Clinical Data Interchange Standards Consortium (CDISC) standards is mandatory for new drug applications (NDAs). The standards set by CDISC are widely adopted in the pharmaceutical business world. Introduction of CDISC standards in academia can be necessary to reduce labor, resolve the shortage of data managers in academia, and gain new knowledge through standardized data accumulation. However, the introduction of CDISC standards has not progressed in communities within the academia that do not apply for NDAs. Therefore, herein, we created study data tabulation model (SDTM)-compliant datasets within the academia, without outsourcing, to reduce costs associated with investigator-initiated clinical trials. First, we input data from paper case report forms (CRFs) into an electronic data capture system with minimal function for paper CRFs, “Ptosh,” which is compatible with SDTM. Then, we developed a generic program to convert data exported from Ptosh into fully SDTM-compliant datasets. The consistency was then verified with an SDTM validator, Pinnacle21 Community V3.0.1 (P21C). This resulted in generation of SDTM datasets, resolving all “Rejects” in P21C, thereby achieving the required quality level. Although Ptosh directly exports data in SDTM format, manual mapping of items on CRFs to SDTM variables prepared in Ptosh is necessary. SDTM mapping requires extensive knowledge and skills, and it was assumed that mapping is challenging for the staff without in-depth knowledge of CDISC standards and datasets. Therefore, for CDISC dissemination in academia, it is crucial to secure the staff, time, and funding to acquire the knowledge.", "subitem_description_language": "en", "subitem_description_type": "Abstract"}, {"subitem_description": "This is an Open Access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. To view the details of this license, please visit (http://creativecommons.org/licenses/by-nc-nd/4.0/).", "subitem_description_language": "en", "subitem_description_type": "Other"}]}, "item_9_identifier_registration": {"attribute_name": "ID登録", "attribute_value_mlt": [{"subitem_identifier_reg_text": "10.18999/nagjms.84.1.120", "subitem_identifier_reg_type": "JaLC"}]}, "item_9_publisher_32": {"attribute_name": "出版者", "attribute_value_mlt": [{"subitem_publisher": "Nagoya University Graduate School of Medicine, School of Medicine", "subitem_publisher_language": "en"}]}, "item_9_relation_43": {"attribute_name": "関連情報", "attribute_value_mlt": [{"subitem_relation_type": "isVersionOf", "subitem_relation_type_id": {"subitem_relation_type_id_text": "https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/841.html", "subitem_relation_type_select": "URI"}}]}, "item_9_source_id_7": {"attribute_name": "収録物識別子", "attribute_value_mlt": [{"subitem_source_identifier": "0027-7622", "subitem_source_identifier_type": "PISSN"}, {"subitem_source_identifier": "2186-3326", "subitem_source_identifier_type": "EISSN"}]}, "item_access_right": {"attribute_name": "アクセス権", "attribute_value_mlt": [{"subitem_access_right": "open access", "subitem_access_right_uri": "http://purl.org/coar/access_right/c_abf2"}]}, "item_creator": {"attribute_name": "著者", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Takahara, Shizuko", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Saito, Toshiki I.", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Imai, Yasuhito", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Kawakami, Takahiro", "creatorNameLang": "en"}]}, {"creatorNames": [{"creatorName": "Murayama, Toshinori", "creatorNameLang": "en"}]}]}, "item_files": {"attribute_name": "ファイル情報", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_access", "date": [{"dateType": "Available", "dateValue": "2022-02-28"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "12_Takahara.pdf", "filesize": [{"value": "1.7 MB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "mimetype": "application/pdf", "size": 1700000.0, "url": {"objectType": "fulltext", "url": "https://nagoya.repo.nii.ac.jp/record/2002124/files/12_Takahara.pdf"}, "version_id": "5df3d700-16c6-4c9e-b751-b47a382a345d"}]}, "item_keyword": {"attribute_name": "キーワード", "attribute_value_mlt": [{"subitem_subject": "CDISC", "subitem_subject_language": "en", "subitem_subject_scheme": "Other"}, {"subitem_subject": "SDTM", "subitem_subject_language": "en", "subitem_subject_scheme": "Other"}, {"subitem_subject": "investigator-initiated clinical trial", "subitem_subject_language": "en", "subitem_subject_scheme": "Other"}, {"subitem_subject": "clinical data management", "subitem_subject_language": "en", "subitem_subject_scheme": "Other"}, {"subitem_subject": "academia", "subitem_subject_language": "en", "subitem_subject_scheme": "Other"}]}, "item_language": {"attribute_name": "言語", "attribute_value_mlt": [{"subitem_language": "eng"}]}, "item_resource_type": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"resourcetype": "departmental bulletin paper", "resourceuri": "http://purl.org/coar/resource_type/c_6501"}]}, "item_title": "A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial", "item_titles": {"attribute_name": "タイトル", "attribute_value_mlt": [{"subitem_title": "A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial", "subitem_title_language": "en"}]}, "item_type_id": "40001", "owner": "1", "path": ["1646019880489"], "permalink_uri": "https://doi.org/10.18999/nagjms.84.1.120", "pubdate": {"attribute_name": "PubDate", "attribute_value": "2022-02-28"}, "publish_date": "2022-02-28", "publish_status": "0", "recid": "2002124", "relation": {}, "relation_version_is_last": true, "title": ["A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial"], "weko_shared_id": -1}