임상시험 모니터링

구분 피험자 현황 임상시험용 의약품 관리 기록 아니오 과제 기본정보 임상시험용 의약품 투약관련 해당없음 명 5. 임상시험용의약품 처방전 : 수불 기록과 처방전 일치 여부 2. 재고 관리 정확성 : 기록과 실물 재고의 일치 여부 수정 요청사항 및 comment 임상시험진행현황 구분 모니터링 내용 임상시험용 의약품 관리 기록 모니터링 항목 1. 관리약사 CV 임상시험용 의약품 보관 임상험약국 관련 서류 요청 2. 온도기록지의 정기적인 관리여부 : 기록상태 및 update 상태 3. 유효기간 관리 적절성 예 2. Source documents의 사본 5. 임상시험용의약품 처방전 : 수불 기록과 처방전 일치 여부 2. 재고 관리 정확성 : 기록과 실물 재고의 일치 여부 임상시험용 의약품 관리 기록 임상시험용 의약품 보관 2. 온도기록지의 정기적인 관리여부 : 기록상태 및 update 상태 3. 유효기간 관리 적절성 임상시험용 의약품 투약관련 2. Source documents의 사본 1. 관리약사 CV 임상험약국 관련 서류 요청 계획 피험자 수 : 명 진행 중인 피험자 지난 모니터링 이후 참여 중단 피험자 모니터링 항목별 특이사항

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						<value>3</value>
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		<caption id="caption41" class="cell_2" visibility="visible" style="left:947px; top:41px; width:85px; height:23px; vertical-align:middle; ">저장 이력</caption>
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				<![CDATA[
					fChgRecHistInfo();				
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