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KMID : 0370220200640050358
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Yakhak Hoeji
2020 Volume.64 No. 5 p.358 ~ p.368
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Current status and examples of patient registries in the US, Europe, and Japan and proposal of planning patient registry in Korea
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Lee Jeong-Eun
Shim Da-Young
Yoon Dong-Won
Noh Yun-Ha
Shin Ju-Young
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Abstract
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Over the past years regulatory agencies of Europe, the United States, and Japan have announced policies tofacilitate the establishment and utility of registries at the national level in order to enhance post-marketing surveillance.
With the recent increase in medical products safety issues, the Ministry of Food and Drug Safety (MFDS) is planning tobuild a patient registry system to monitor the safety of problematic products. The objective of this study is to examinethe initiatives and the activities of health authorities in the US, Europe, and Japan and identify the essential features ofwell-operated registries. We collected information from official documents and postings on the health authority’shomepages about activities and efforts of the initiatives. We also surveyed and analyzed the official reports, the guide foreach stakeholder of registries, and the information sheets for patients or doctors as case studies of well-designed registries.
Therefore, this study suggests future directions on how to plan a long-term follow-up system and on how to designnational level registries in Korea.
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KEYWORD
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Registry, patient registration, patient safety, long-term follow up
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