Points to Consider for Development and Introduction of Electronic Data Capture System in Japan and Its Future Perspectives with Respect to the Current Situation
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Accession number;03A0794397
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| Title;Points to Consider for Development and Introduction of Electronic Data Capture System in Japan and Its Future Perspectives with Respect to the Current Situation |
| Author;
FUKAZAWA ICHIRO
(Takeda Chem. Ind., Ltd.)
HATANAKA YUSUKE
(Acronet)
TAMURA YOSUKE
(Asutorazeneka)
ITO NOBUYUKI
(CAC Corp., JPN)
MIZUNO TAKAHIDE
(Ipiesu)
OKUNO JUN
(Nihonwaisuredari)
TOMODA HIROKO
(Daiichi Pharm. Co., Ltd.)
FURUKO MIHO
(Nippon Boehringer Ingelheim Co., Ltd.)
UJO YASUKO
(Kirin Brewery Co., Ltd., JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.10;PAGE.1175-1213(2003)
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| Figure&Table&Reference;FIG.4, TBL.10 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The purpose of this document is to provide a suggestion to biopharmaceutical companies, CROs, IT venders or investigative sites on practices for the development or introduction of EDC (Electronic Data Capture) system for clinical trials in Japan. We have summarized the regulatory requirements concerned with EDC in Japan, whereas the regulatory requirements concerned with EDC in the U.S. and Europe were just referenced. The appeal to the M.H.L.W. is one of the important factors in developing EDC in the Japan. We have studied the benefits and shortcomings that may occur by the introduction of EDC in terms of the speed of clinical trials, integrity of the data, costs and the standpoint of medical institutions. We could enjoy a great deal of benefits by changing our roles and operation flows. In addition, we could overcome most of its shortcomings. The following were examined: our roles of relevant personnel, logical check, telecommunication security, input interface and input in the light of the current technology. These items require changes from old ideas to new ones some of which should increase their importance upon the introduction of eCRF as compared with paper CRF. Points to consider at the time of developing or selecting the EDC system were reviewed i.e., how it should be developed, what function are required and what operating techniques should be employed. When introducing the EDC system, it is important to select a more general system. In view of how EDC should be in the future, we should look to the future course of DISC and electric medical records. Lastly let me introduce the EDC system that is available in Japan as of Aug. 2003. (author abst.) |
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