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N 「의약품 임상시험 등 종사자 교육 및 교육실시기관 지정에 관한 규정」(식약 처고시 제2017-79호(2017.10.20.)) [별표 1]에서 '시험책임자의 위임 및 감 독에 따라 임상시험등 업무를 담당하는 사람'을 '임상시험등 업무 담당자'로 정의하고 있습니다. - 시험책임자의 위임 및 감독에 따라 채혈 업무를 담당하는 경우에는 임상시험등 업무 담당자로서, [별표 1]에서 정하는 바*에 따라 교육을 받아야 합니다. * 신규자 교육과정(우선 교육 시간) : 4시간 이상 (2시간 이상) - 임상시험 대상자들의 안전 등의 이유로 밤에 순회하는 역할만 하는 직원의 경우에는 시험 책임자의 위임 및 감독에 따른 업무 범위가 아니라면 임상시험등 종사자 교육대상이 아닐 것입니다. ※ 약사법 제34조(임상시험등의 계획 승인 등) IRB에 문의하시는게 좋을듯

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