Application of Electronic Data Capture System to a Clinical Study in Japan

KAWAI Akiyoshi, KUWANO Tomoaki, NAKAJIMA Hisao, MIZUNO Kiyofumi, NISHIMOTO Hiroyuki, KUBOTA Nobuko

doi:10.3999/jscpt.34.4_193

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Other Title

日本の臨床試験におけるＥＤＣ（Ｅｌｅｃｔｒｏｎｉｃ　Ｄａｔａ　Ｃａｐｔｕｒｅ）の適用

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Description

The major factors that have heretofore prevented an efficient implementation of clinical trials include deviations from the protocol at the investigator's site, defectiveness in filling out the case report forms (CRFs), frequent monitoring and fixing work of patient data by the sponsor, handwritten preparation of various documents, and so on.<BR>As an experiment in electronic implementation of an efficient clinical trial utilizing information technology, we formed an electronic data capture (EDC) system that efficiently collects clinical data from the investigator's site, and applied it to a clinical trial. As a result, there was no patient with a GCP violation and thus all were eligible as study subjects and the number of correction log form (CLF) for CRFs was considerably reduced. In addition, it was possible to conduct an efficient clinical trial and shorten the study period by utilizing this EDC system. We discuss the future readiness for clinical trials based on this experience of implementation, as well as the challenges that lie ahead.

Journal

Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics

Rinsho yakuri/Japanese Journal of Clinical Pharmacology and Therapeutics 34 (4), 193-198, 2003

The Japanese Society of Clinical Pharmacology and Therapeutics

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Details 詳細情報について

CRID: 1390001205366601984

NII Article ID: 10016998220

NII Book ID: AN0025404X

DOI: 10.3999/jscpt.34.4_193

ISSN: 18828272; 03881601

Web Site: https://search.jamas.or.jp/link/ui/2003314911

Text Lang: ja

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