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- 교육받고 다음 임상연구심의위원회의를
- 참관하였음을 확인합니다
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- <제 차 임상연구심의위원회의>
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- 임상연구계획서제목/접수과/시험책임자/연구의 종류/단계(허가용/연구용,Phase)
- 연구대상: 의약품[세포치료제,유전자치료제]/의료기기/건강기능식품 등
- 2) 임상연구의 목적, 방법, 대상군 등을 간략히 설명함.
- 3) 미리 작성해 온'연구 계획서체크리스트'와 '피험자동의 체크리스트'등을 통하여 피험자가 얻을 수
- 있는 이익 및 위험과 위험을 최소화할 수 있는 방안 등 자신의 심의 의견을 먼저 발표함.
- 4) 연구의 위험에 비추어 결정한'중간보고/지속심의'주기에 대한 의견을 발표함.
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자16" Visible="0" X1="50" Y1="778" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="* 강남성모병원 임상연구심의위원회/기관생명윤리심의위원회 표준운영지침서" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자17" Visible="0" X1="50" Y1="900" Width="1900" Height="450" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text=" 5. "상임위원"은 정규심의의 원활한 진행을 위하여 정규심의에 항시 참석하여 의견을
- 제출하는 위원으로서 약리학 전문가, 통계 전문가, 윤리 전문가와 기관과 관계가 없는
- 비전문가로 구성 한다. 전문적인 심의를 위하여 자주 심의되는 계획서의 종류에 따라 2명
- 이상의 임상전문의를 포함시킨다. 정규심의에 제출된 모든 연구계획서에 대하여 담당
- 분야를 사전검토 해야 한다. 참석이 불가한 경우에는 서면으로 의견을 제출해야 하며, 그
- 위원은 정족수에 포함되지 않는다" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자18" Visible="0" X1="50" Y1="850" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="제 5 조 (구성) " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="1" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자19" Visible="0" X1="50" Y1="1400" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="제 9 조 (책임심의위원)" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="1" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자20" Visible="0" X1="50" Y1="1450" Width="1900" Height="300" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text=" 1. 책임심의위원은 정규심의를 원할하게 하기 위하여 배정된 과제에 대해 상세히 검토한 후
- 심의 내용을 전문간사에게 전달하고, 정규심의에서 발표하는 위원을 말한다.
- 2. 책임심의위원이 정규심의에서 발표할 때는 연구자의 교육이수 사항 및 연구팀의 적절한
- 연구능력 보유 등 '연구계획서체크리스트'에 있는 사항들을 중심으로 발표한다.
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자21" Visible="0" X1="50" Y1="1800" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="제 35 조 (정규심의회의)" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="1" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자22" Visible="0" X1="50" Y1="1900" Width="1900" Height="750" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1) 정규심의회의는 규칙적으로 정하여진 일정에 따라 열려야 한다. 필요에 따라 긴급
- 회의가 개최될 수 있다.
- 2) 의약품 및 기타 심의 회의는 월 2회 (매월 제2주 화요일, 제4주 수요일) 개최하고,
- 생명윤리심의위원회와 의료기기심의위원회는 월 1회 개최한다.
- 3) 회의자료는 적절한 심의를 위해 정규심의 개최 적어도 일주일 전에 심의위원들 에게
- 배부되어야 한다.
- 4) 정규심의회의 전에 접수된 연구계획서의 심의를 원활히 진행하기 위하여 책임심의위원
- 제도와 상임위원제도를 둔다.
- 5) 제출된 초기 연구계획서는 책임심의위원을 배정하며, 책임심의위원은 정규심의에서
- 담당한 연구계획서의 내용을 요약 발표하고 이의 위험/이익 및 취약한 피험자에 관한 " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="70" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자23" Visible="0" X1="50" Y1="1850" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1. 회의규칙" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control></ListControls><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="2" Name="보고서바닥글" Height="300" Visible="3" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"/><ConditionalStyles/><Script><![CDATA[]]></Script></Section></Page><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"/></Report><Script><![CDATA[]]></Script></Section><Section Type="512" Name="서브리포트섹션3" Height="300" Visible="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" FollowMainReport="1" UseMainReportData="0" PageReset2="1"><FieldLinks/><ConditionalStyles/><Report Title="" Author="" Company="" Category="" Description="" CreatedDate="" LastSavedDate="" Version=""><FieldInfo><FieldSet ID="1"/><FieldSet ID="2"/><FieldSet ID="3"/><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="0" DataPath="" DataRoot="" XslPath="" XsdPath="" CsvPath="" CsvRowSeparator="" CsvColumnSeparator=""><OrderInfos/><FilterInfos/><SPInfo FunctionName=""/><SQL></SQL><ServerConnection URL="" DataType=""/></DataSetting><GlobalStyleManager/><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"/><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="252" Visible="3" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"/><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="64" Name="본문" Height="2861" Visible="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="1" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"><Control Type="Control.Label" Name="글상자24" Visible="0" X1="50" Y1="50" Width="1900" Height="2100" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text=" 사항을 포함한 '연구계획서체크리스트'를 발표한다.
- 6) 나머지 심의위원들은 피험자 동의서 사본과 동의서에 있는 연구 내용의 적절성을 판단할
- 수 있는 정도로 충분히 자세하게 기술된 계획서 요약본을 받는다.
- 7) 행정간사는 과제별 연구책임자가 현재 진행중인 과제의 수를 확인하여 심의 첨부자료로
- 제시한다. 이 내용은 연구책임자의 현재 연구수행 능력에 대한 심의에 반영되도록 한다.
- 8) 정규심의에서 계획서, 재심의 보완서류, 결과보고서 심의의 판정에 대해 책임심의위원의
- 의견을 종합하여, 출석한 심의위원들의 투표에 의해 과반수 이상의 의견으로 심의
- 결과를 판정한다.
- 9) 정규심의에서 모든 심의위원들은 제출된 모든 자료를 볼 수 있어야 한다.
- 10) 회의 시 모든 발표는 비전문가도 쉽게 이해할 수 있는 언어로 설명한다.
- 11) 위원회에 출석한 심의위원은 위원회에 접수된 모든 계획서를 심의한다. 단 신속심의
- 요건에 해당하는 건은 추인하는 것을 원칙으로 한다.
- 12) 연구책임자가 위원회 위원인 경우 해당 연구의 심의에는 참여할 수 없다
- 13) 위원회는 필요 시 관련 전문가를 자문위원으로 위촉하여 의견을 들을 수 있으나
- 자문위원은 심의에 참여할 수 없다
- 14) 위원회는 연구책임자에게 연구에 관한 구두 설명, 보충 자료의 제출을 요구할 수 있다.
- 15) 정족수 및 찬반 투표 결과는 매 안건 심의마다 확인되고 회의록에 기록한다.
- 16) 모든 계획서의 위원회 승인은 별도의 위원회 결정이 없는 한 1년간 유효하다.
- 17) 연구책임자는 연구계획의 초기 심의, 연구진행과정에서 발생한 문제에 대한
- 심의과정에서 위원회가 출석을 요구할 때는 반드시 참석하여야 한다.
- 18) 위원장은 연구자 및 의뢰자와 관련이 없는 위원에 한하여 심의과정에 참여하게 하거나
- 의견을 제시할 수 있도록 하여야 한다.
- 19) 위원장은 연구책임자가 위원회의 위원에게 영향을 미치거나 해당 연구와 관련된 사항의
- 결정과정에 참여할 수 없도록 하여야 한다.
- 20) 위원장은 위원회에 출석한 위원에게 심의할 연구과제와 이해갈등의 관계가 있는지
- 물어보고 관계가 있는 위원은 퇴장토록 한다.
- 21) 연구책임자가 심의되는 내용에 대해 직접 소명하고자 할 때에는 위원회에 그 의사를
- 전달할 수 있으며, 위원회는 그 사유가 적절하다고 판단될 때에 위원회 출석을 허용할
- 수 있다.
- 22) 임상시험 계획서 심의 시 식약청 승인 대상여부를 반드시 확인해야 한다
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="70" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자25" Visible="0" X1="50" Y1="2200" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="2. 회의 진행 절차 : 정규 회의는 다음과 같은 순서로 진행한다." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자26" Visible="0" X1="50" Y1="2250" Width="1900" Height="300" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자27" Visible="0" X1="50" Y1="2250" Width="1900" Height="600" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1) 개회선언
- 2) 시작기도
- 3) 의사정족수 확인
- 4) 심의 위원들과 심의할 임상연구 사이의 이해갈등 여부 확인
- 5) 지난 회의록 검토 및 승인(단, 같은 팀의 회의에 대한 회의록)
- 6) 지난 정규심의 이후 시행된 신속심의 내용 보고
- 7) 초기계획서의 신속심의 (제목, 시험책임자)
- 8) 보완답변서의 신속심의 (제목, 시험책임자)
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control></ListControls><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="2" Name="보고서바닥글" Height="300" Visible="3" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"/><ConditionalStyles/><Script><![CDATA[]]></Script></Section></Page><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"/></Report><Script><![CDATA[]]></Script></Section><Section Type="512" Name="서브리포트섹션4" Height="300" Visible="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" FollowMainReport="1" UseMainReportData="0" PageReset2="1"><FieldLinks/><ConditionalStyles/><Report Title="" Author="" Company="" Category="" Description="" CreatedDate="" LastSavedDate="" Version=""><FieldInfo><FieldSet ID="1"/><FieldSet ID="2"/><FieldSet ID="3"/><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="0" DataPath="" DataRoot="" XslPath="" XsdPath="" CsvPath="" CsvRowSeparator="" CsvColumnSeparator=""><OrderInfos/><FilterInfos/><SPInfo FunctionName=""/><SQL></SQL><ServerConnection URL="" DataType=""/></DataSetting><GlobalStyleManager/><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"/><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="50" LeftMargin="50" BottomMargin="50" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="300" Visible="3" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="0" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"/><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="64" Name="본문" Height="2847" Visible="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" CanShrink="0" ColumnWidth="0" ColumnDirection="0" ColumnSpacing="0" ColumnLayout="0" Repeat="0" UnderlayNext="0" DetailIteration="0" ForcedGH="0" KeepTogether="1" NewColumn="0" NewPage="0" PrintAtBottom="0" PageReset="0" SuppressBlankSection="0" SuppressRepeatedBlankSection="1" FillBlank="0" Exportable="1" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"><Control Type="Control.Label" Name="글상자28" Visible="0" X1="50" Y1="50" Width="1900" Height="650" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="9) 변경계획서의 신속심의 (제목, 시험책임자)
- 10) 종료보고서의 신속심의 (제목, 시험책임자)
- 11) 중대한이상반응 보고 신속심의 (세부사항 요약)
- 12) 연구계획서 심의(시험책임자의 현재진행중인 임상시험계획서수와 진행인력여건 함께 심의), 토론, 투표
- 13) 지속심의신청서의 심의(시험책임자의 현재진행중인 임상시험계획서수와 진행인력여건 함께 심의), 토론, 투표
- 14) 결과보고서의 심의, 토론, 투표
- 15) 기타안건 논의 또는 결정
- 16) 마침 기도
- 17) 폐회 선언
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자29" Visible="0" X1="50" Y1="750" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="3. 투표절차 : 다음과 같은 요건을 만족시켜야 한다." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자30" Visible="0" X1="50" Y1="800" Width="1900" Height="1200" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1) 위원회가 성립하기 위해서는 5인 이상의 위원들이 참석하여야 한다.
- 2) 연구 활동이 심의되는 모든 회의에는 기관 외부의 인사 및 비전문가(법률가 또는
- 종교인, 윤리전문가 등)가 반드시 참석하여야만 한다.
- 3) 약품이나 생물학 제재, 의료기기 등을 다루는 연구 활동의 심의에는 의사가 최소한 한
- 사람은 반드시 참석하여야만 하다.
- 4) 위원만이 투표할 수 있다.
- 5) 현재 심의하고 있는 안건과 이해갈등관계가 있는 위원은 투표할 수 없다.
- 6) 연구를 승인하기 위해서는 출석 위원 중 과반수의 위원들이 찬성하여야 한다.
- 대리투표는 인정하지 않는다.
- 7) 필요하다면 전화 또는 화상회의 등을 통해 회의를 진행할 수 있다. 이를 위해서는 회의
- 이전에 모든 위원들이 적절한 자료를 제공받아야 하며, 참석한 경우와 동일하게
- 적극적으로 회의를 진행할 수 있어야 한다. 이러한 회의의 경우, 회의록에는 여타 법규가
- 요구하는 조건 이외에도 위의 두 가지 조건이 충족되었음이 분명하게 기록되어야 한다.
- 8) 정족수는 매 안건에 대한 심의마다 확인되고 회의록에 기록되어야 한다. (찬반투표
- 결과(예: 총인원-10; 찬성-8, 반대-1, 기권-1), 부결 또는 수정 요구의 근거, 승인
- 기간(심의 간격)에 대한 결정 사항)
- 9) 연구가 승인되면 위원회는 각 연구의 중간보고 주기를 결정한다.
- " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="10" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자31" Visible="0" X1="50" Y1="2050" Width="1900" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="4. 회의 결과 : 위원회는 연구계획에 대해 다음 6가지의 결정을 내릴 수 있다." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="50" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자32" Visible="0" X1="50" Y1="2100" Width="1900" Height="650" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1) 승인한다 (승인)
- 2) 조건부로 승인한다 (조건부 승인):
- 위원회가 요구한 대로 시정되면 행정간사의 확인을 거쳐 승인한다.
- 3) 자료보완이 요구됨 (시정 승인):
- 일정한 결정사항에 대해 수정 내지 추가 자료를 요구하며, 신속심의 한다.
- 4) 재검토가 요구된다 (보완 후 재심)
- 일정한 결정사항에 대해 수정 내지 추가자료를 요구하며 정규심의 한다.
- 5) 승인치 않는다 (반려)
- 6) 승인된 임상시험을 중지 또는 보류한다 (중지/보류)
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