임상시험 전자 자료 관리의 해외 규정 비교를 통한 전자자료 관리 기준 고찰
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Objectives:The use of electronic data management has grown to progressively replace paper-based clinical trials. Electronic data management must ensure the same data quality expected of paper clinical trials, by following Good Clinical Practice rules and relevant regulations. There was Korean Good Clinical Practice, however need more specific regulation to provide detail guideline. This study aims to compare international regulations for electronic clinical data management and explore the direction for Korean regulation for electronic clinical trials. Methods:Three international regulations, 21 CFR 11 of FDA, ANNEX 11 of EMEA, or ERES of Japan, are compared to find out requirements for quality, security and integrity of data. Requirements are analyzed through three perspectives; electronic records, electronic signatures and computerized systems. Results:Regulations commonly stated that electronic record should develop standard operation procedure, audit trail, features to copy records. In addition, time-stamped, record backup and accurate archival are proposed. Regulations for electronic signatures are precisely described in the FDA and Japan regulation. Finally, computerized system should be validated, and have security control, access control, and contingency plan. Conclusions:This study compared the representative regulations from three regulations and proposed recommended features for Korean regulation. This result can be provided to develop Korean regulation for electronic data management. Key word: electronic clinical trial, clinical trial regulation, good clinical practice
Abstract
Objectives:The use of electronic data management has grown to progressively replace paper-based clinical trials. Electronic data management must ensure the same data quality expected of paper clinical trials, by following Good Clinical Practice rules and relevant regulations. There was Korean Good Clinical Practice, however need more specific regulation to provide detail guideline. This study aims to compare international regulations for electronic clinical data management and explore the direction for Korean regulation for electronic clinical trials. Methods:Three international regulations, 21 CFR 11 of FDA, ANNEX 11 of EMEA, or ERES of Japan, are compared to find out requirements for quality, security and integrity of data. Requirements are analyzed through three perspectives; electronic records, electronic signatures and computerized systems. Results:Regulations commonly stated that electronic record should develop standard operation procedure, audit trail, features to copy records. In addition, time-stamped, record backup and accurate archival are proposed. Regulations for electronic signatures are precisely described in the FDA and Japan regulation. Finally, computerized system should be validated, and have security control, access control, and contingency plan. Conclusions:This study compared the representative regulations from three regulations and proposed recommended features for Korean regulation. This result can be provided to develop Korean regulation for electronic data management. Key word: electronic clinical trial, clinical trial regulation, good clinical practice
참고문헌 (20)
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