| Item type |
itemtype_ver1(1) |
| 公開日 |
2022-02-28 |
| タイトル |
|
|
タイトル |
A use-case analysis of Clinical Data Interchange Standards Consortium/Study Data Tabulation Model in academia in an investigator-initiated clinical trial |
|
言語 |
en |
| 著者 |
Takahara, Shizuko
Saito, Toshiki I.
Imai, Yasuhito
Kawakami, Takahiro
Murayama, Toshinori
|
| アクセス権 |
|
|
アクセス権 |
open access |
|
アクセス権URI |
http://purl.org/coar/access_right/c_abf2 |
| 権利 |
|
|
言語 |
en |
|
権利情報Resource |
http://creativecommons.org/licenses/by-nc-nd/4.0/ |
|
権利情報 |
Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
CDISC |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
SDTM |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
investigator-initiated clinical trial |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
clinical data management |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
academia |
| 内容記述 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
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. |
|
言語 |
en |
| 出版者 |
|
|
出版者 |
Nagoya University Graduate School of Medicine, School of Medicine |
|
言語 |
en |
| 言語 |
|
|
言語 |
eng |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
departmental bulletin paper |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| ID登録 |
|
|
ID登録 |
10.18999/nagjms.84.1.120 |
|
ID登録タイプ |
JaLC |
| 関連情報 |
|
|
関連タイプ |
isVersionOf |
|
|
識別子タイプ |
URI |
|
|
関連識別子 |
https://www.med.nagoya-u.ac.jp/medlib/nagoya_j_med_sci/841.html |
| 助成情報 |
|
|
|
助成機関名 |
日本学術振興会 |
|
|
言語 |
ja |
|
|
助成機関名 |
Japan Society for the Promotion of Science |
|
|
言語 |
en |
|
|
研究課題番号URI |
https://kaken.nii.ac.jp/grant/KAKENHI-PROJECT-15K15250/ |
|
|
研究課題番号 |
15K15250 |
|
|
研究課題名 |
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 |
|
|
言語 |
ja |
| 収録物識別子 |
|
|
収録物識別子タイプ |
PISSN |
|
収録物識別子 |
0027-7622 |
| 収録物識別子 |
|
|
収録物識別子タイプ |
EISSN |
|
収録物識別子 |
2186-3326 |
| 書誌情報 |
en : Nagoya Journal of Medical Science
巻 84,
号 1,
p. 120-132,
発行日 2022-02
|
12_Takahara.pdf (1.7 MB)
.png)
