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
アイテムタイプ
学術雑誌論文 / Journal Article
言語
日本語
キーワード
electronic data capture (EDC), clinical data, clinical research coordinator (CRC), questionnaire survey
日本臨床薬理学会 = The Japanese Society of Clinical Pharmacology and Therapeutics
抄録
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.
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
PH-PR-MIYAMOTO-K-235.pdf
(1.2MB)
