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治験のIT化に必要なEDCシステム運用に関する現状調査に基づく提言
http://hdl.handle.net/2297/35915
http://hdl.handle.net/2297/359153ea0642c-d116-4204-beaa-d9335fd18c15
| 名前 / ファイル | ライセンス | アクション |
|---|---|---|
PH-PR-MIYAMOTO-K-235.pdf (1.2 MB)
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| Item type | 学術雑誌論文 / Journal Article(1) | |||||
|---|---|---|---|---|---|---|
| 公開日 | 2017-10-03 | |||||
| タイトル | ||||||
| タイトル | 治験のIT化に必要なEDCシステム運用に関する現状調査に基づく提言 | |||||
| タイトル | ||||||
| タイトル | Proposals for the Advancement of Utilization of Information Technology in Clinical Trials based on the Analysis of a Questionnaire Survey of the Current Problems in EDC Systems | |||||
| 言語 | en | |||||
| 言語 | ||||||
| 言語 | jpn | |||||
| 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 | journal article | |||||
| 著者 |
小川, 智美
× 小川, 智美× 古川, 裕之× 宮本, 謙一 |
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| 書誌情報 |
臨床薬理 = Japanese journal of clinical pharmacology 巻 40, 号 5, p. 235-242, 発行日 2009-01-01 |
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| ISSN | ||||||
| 収録物識別子タイプ | ISSN | |||||
| 収録物識別子 | 0388-1601 | |||||
| NCID | ||||||
| 収録物識別子タイプ | NCID | |||||
| 収録物識別子 | AN0025404X | |||||
| DOI | ||||||
| 関連タイプ | isIdenticalTo | |||||
| 識別子タイプ | DOI | |||||
| 関連識別子 | 10.3999/jscpt.40.235 | |||||
| 出版者 | ||||||
| 出版者 | 日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics | |||||
| 抄録 | ||||||
| 内容記述タイプ | Abstract | |||||
| 内容記述 | In recent years, the use of the EDC system in clinical trials has expanded rapidly. Many medical institutions have accepted the installation of the EDC system for clinical trials. However, a few systems reflect a paticular opinion on the data entry side in former system development. Therefore, we undertook an investigation which focused on the problems of the system and based on the results we considered means of improvement for enhanced usability of the EDC system. A questionnaire survey was sent to CRCs which are the clinical trial implementation hospitals of national organizations and university hospitals (in total 131 facilities), the 61 member companies of Japanese SMO society, and the attendees of luncheon seminars 1 and 2 of CRC meeting 2008 in Kanazawa. A total of 811 questionnaire survey responses were obtained. Of the respondents 93.6% had prior experience using the EDC system, and 69.5% implementing EDC system with English entry. The items with the most frequent responses were training program (38%), inconsistent entry form (36%), the limitation of the usable system (34%), data entry using English language (31%) and management of identification number and password (28%). The EDC system has rapidly become popular, and it is expected that use of the EDC system with English entry will increase in the future. In this investigation, problems such as system improvement in the design process and interface were extracted. These problems have been extracted for system improvement, and based on the addressing these problems there is hope for the realization of correct and quick data acquisition. | |||||
| 権利 | ||||||
| 権利情報 | Copyright © The Japanese Society of Clinical Pharmacology and Therapeutics | 許可を得て登録 | |||||
| 著者版フラグ | ||||||
| 出版タイプ | VoR | |||||
| 出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | http://www.jscpt.jp/ | |||||
| 関連URI | ||||||
| 識別子タイプ | URI | |||||
| 関連識別子 | https://www.jstage.jst.go.jp/browse/jscpt/-char/ja/ | |||||
