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PRIIA00125_신속심사체크리스트.rex

PRIIA00125_신속심사체크리스트.rex 127 KB
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  1. <?xml version="1.0"?>
    2. 

  2. <Report Title="" Author="" Company="" Category="" Description="" CreatedDate="2008-01-16 21:16:55" LastSavedDate="2009-12-08 11:29:15" Version="2.5.1.93"><FieldInfo><FieldSet ID="1"><Field Name="judgdd" Type="8" Size="0" Xpath="judgdd"/><Field Name="subjno" Type="8" Size="0" Xpath="subjno"/><Field Name="respstdynm" Type="8" Size="0" Xpath="respstdynm"/><Field Name="respstdyhospnm" Type="8" Size="0" Xpath="respstdyhospnm"/><Field Name="respstdydeptnm" Type="8" Size="0" Xpath="respstdydeptnm"/><Field Name="subjnm" Type="8" Size="0" Xpath="subjnm"/></FieldSet><FieldSet ID="2"/><FieldSet ID="3"><Field Name="hospdeptNm" ScriptType="1"><![CDATA[return "{@respstdyhospnm}" + " / " + "{@respstdydeptnm}"]]></Field></FieldSet><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="2" DataPath="D:\CMCOracle\application\webapps\crc\irbsubweb\rex\PRIIA00125.xml" DataRoot="root/main/rexjudgspdlist/item" XslPath="" XsdPath="" 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Alignment="1" VerticalAlignment="1" Text="신속심사 Checklist" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="14" 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.Table" Name="표1" Visible="0" X1="50" Y1="150" Width="1900" Height="140" FitSection="0" LinkIndex="4" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="1" RightLineStyle="1" TopLineStyle="1" BottomLineStyle="1" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0.75" 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WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="9" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="0" FieldIndex="2" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row></Rows><Cols><Col Size="633"/><Col Size="633"/><Col Size="634"/></Cols><ConditionalStyles/></Control></ListControls><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="64" Name="본문" Height="330" 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.Table" Name="표2" Visible="0" X1="50" Y1="50" Width="1900" Height="280" FitSection="0" LinkIndex="5" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="1" RightLineStyle="1" TopLineStyle="1" BottomLineStyle="1" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0.75" RightLineWidth="0.75" TopLineWidth="0.75" BottomLineWidth="0.75" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="140"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="본 Checklist의 목적은 임상연구의 초기심사가 신속심사 대상일 경우 신속심사의 기준을 제시함에 있다.
    3. 

  3. 신속심사위원은 심사과제마다 본 checklist 1부를 작성하여 IRB 에 제출하고, 연구윤리행정은 이를 보관한다." 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ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="2" BaseCellColIndex="0"/></Row><Row Size="70"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="  예       아니오" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" 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Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="피험자에 대한 위험이 '최소한의 위험 ' 이내로 변경되는 경우" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="140"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="2" CanGrow="0" 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    4. 

  4.   해당없음" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="아래 (1) ~ (7) 에 해당하는 과정이 하나 이상 추가되는 경우
    5. 

  5. (추가가 없는 경우 &quot;해당없음&quot; 예 표기)" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="3" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="70"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="3. 초기심사 또는 지속 심사 (신속심사 대상인 경우 모든 항목이 &quot;예&quot; 로 표기되어야 함)" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="2" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="6" BaseCellColIndex="0"/></Row><Row Size="140"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="  예       아니오" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="2" CanGrow="0" CanShrink="0" DataType="0" Text="초기심사: '최소한의 위험 ' 이내의 연구에 해당됨
    6. 

  6. 지속심사: 남아있는 연구 과정이 '최소한의 위험 ' 이내의 연구 또는 아래 (8)(b)에 해당됨" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="350"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="  예       아니오" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="사생활 침해와 관련된 위험이나 개인 기밀의 누설이 최소화 될 수 있도록 합리적이고, 적절한 보호가 이루어지는 연구이거나 아니면,
    7. 

  7. 피험자 개인 식별 또는 피험자 반응의 노출(진행중인 연구의 경우 이에 해당하는 부분)로 인하여 피험자가 민형사상 불이익, 재정*보증*고용*보험 등의 어려움, 명예의 실추 또는 오명을 얻게 되지 않는 연구에 해당됨." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row></Rows><Cols><Col Size="350"/><Col Size="1550"/></Cols><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자15" Visible="0" X1="1010" Y1="290" Width="25" Height="25" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" 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LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control></ListControls><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="49" 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" 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LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Shape" Name="사각형21" Visible="0" X1="434" Y1="998" X2="469" Y2="1033" EndSectionIndex="0" LineStyle="1" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="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.Shape" Name="사각형22" Visible="0" X1="434" Y1="1098" X2="469" Y2="1133" EndSectionIndex="0" LineStyle="1" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="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><ListControls Type="1"><Control Type="Control.Table" Name="표6" Visible="0" X1="50" Y1="0" Width="1900" Height="1190" FitSection="0" LinkIndex="6" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="1" RightLineStyle="1" TopLineStyle="1" BottomLineStyle="1" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0.75" RightLineWidth="0.75" TopLineWidth="0.75" BottomLineWidth="0.75" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="70"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="아래 항목에서 초기심사는 (1)~(7), 지속심사는 (8)~(9) 중 하나를 만족하여야 함 (해당되는 경우 모두 표기)" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="3" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="0"/><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="0"/></Row><Row Size="70"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="초기 심사
    8. 

  8.   예       아니오" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="9" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="30" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(1)(a) 허가용 의약품 임상시험이 아님" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="70"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(1)(b) 허가용 임상시험이 아니면서 품목허가 적응증 내에서 실시되는 의료기기 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="210"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(2)(a) 최소한 50kg 이상의 건강한 성인(여성인 경우 임신하지 않은 성인)으로부터 Finger 
    9. 

  9.    stick, heel stick, ear stick 또는 정맥으로 채혈한  혈액의 양이 8주 동안 550ml 
    10. 

  10.    미만이고, 주당 2회 미만으로 채혈함" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="210"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(2)(b) (2)(a)항에 해당되지 않는 성인이나 소아로부터 finger stick, heel stick, ear stick
    11. 

  11.    또는 정맥으로 채혈한 혈액의 양이 8주 동안 총 50ml 또는 kg 당 3ml 미만이며, 주당 2회
    12. 

  12.    미만으로 채혈함" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="70"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(3) 연구목적을 위한 검체를 비침습적인 과정을 통하여 전향적으로 수집함" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="140"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(4) 일상적으로 임상에서 사용되는 비침습적인 과정을 통하여 자료를 수집함. 단, 전신마취
    13. 

  13.    나 안정제를 사용한 검사, x-ray나 마이크로파 등을 이용한 연구는 해당되지 않음" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="140"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(5) 어떠한 목적으로 이미 수집되거나, 연구를 목적으로 하지 않고 수집될 예정인 재료들
    14. 

  14.    (자료, 문서, 기록, 검체)을 이용하는 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="70"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(6) 연구목적으로 만들어진 음성, 비디오, 디지털, 영상으로 자료를 수집함" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="140"><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(7) 개인 또는 그룹에 대한 특성 또는 행동연구이거나, survey, interview, oral history,
    15. 

  15.    focus group, 프로그램 평가, 인구학적 평가 또는 품질보증방법론에 해당되는 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row></Rows><Cols><Col Size="350"/><Col Size="100"/><Col Size="1450"/></Cols><ConditionalStyles/></Control><Control Type="Control.Label" Name="글상자5" Visible="0" X1="1320" Y1="284" Width="25" Height="25" 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" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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="글상자6" Visible="0" X1="1136" Y1="336" Width="25" Height="25" 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" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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="글상자7" Visible="0" X1="828" Y1="550" Width="25" Height="25" 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" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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="글상자8" Visible="0" X1="1688" Y1="644" Width="25" Height="25" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="6" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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="글상자9" Visible="0" X1="1826" Y1="764" Width="25" Height="25" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="7" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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="글상자10" Visible="0" X1="1856" Y1="1114" Width="25" Height="25" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="8" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="6" 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></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="서브리포트섹션2" Height="51" 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="64" Name="본문" Height="1050" 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" 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ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Shape" Name="사각형29" Visible="0" X1="1090" Y1="718" X2="1125" Y2="753" EndSectionIndex="0" LineStyle="1" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="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.Shape" Name="사각형30" Visible="0" X1="1426" Y1="718" X2="1461" Y2="753" EndSectionIndex="0" LineStyle="1" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="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><ListControls Type="1"><Control Type="Control.Table" Name="표5" Visible="0" X1="50" Y1="0" Width="1900" Height="1050" FitSection="0" LinkIndex="7" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="1" RightLineStyle="1" TopLineStyle="1" BottomLineStyle="1" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0.75" RightLineWidth="0.75" TopLineWidth="0.75" BottomLineWidth="0.75" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="210"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="지속 심사
    16. 

  16.   예       아니오" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="4" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="30" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(8)(a) 이전 IRB 회의에서 승인된 연구의 지속심사로서 (i) 새로운 피험자의 등록이 불가능
    17. 

  17.    한 경우; (ii) 모든 피험자들이 모든 연구와 관련된 중재를 완료한 경우  ; (iii) 단지 피험자
    18. 

  18.    들의 장기간 추적 활동만이 남은 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="4" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="2"/></Row><Row Size="140"><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(8)(b) 이전 IRB 회의에서 승인된 연구의 지속심사로서 현재까지 본원까지 등록된 
    19. 

  19.    피험자가 하나도 없고, 추가적인 위험도 확인되지 않는 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="4" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="1" BaseCellColIndex="2"/></Row><Row Size="140"><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(8)(c) 이전 IRB 회의에서 승인된 연구의 지속심사로서 남아 있는 연구활동이 자료분석만 
    20. 

  20.    있는 연구" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="4" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="2" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="2" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="2" BaseCellColIndex="2"/></Row><Row Size="210"><Cell CellType="1" BaseCellRowIndex="0" BaseCellColIndex="0"/><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="60" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="1" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="(9) 지속심사의 대상 연구가 허가용 임상시험이 아니고, 위의 (2)~(8) 에 해당되지 않으나,
    21. 

  21.    최소한의 위험 이내의 연구로 IRB 가 결정하고 기록하였으며, 추가적인 위험이 확인되지
    22. 

  22.    않은 경우" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="6" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="4" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="0" LeftMargin="30" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="10" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" FieldID="-1" FieldIndex="-1" StyleIndex="0"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell><Cell CellType="1" BaseCellRowIndex="3" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="3" BaseCellColIndex="2"/><Cell CellType="1" BaseCellRowIndex="3" BaseCellColIndex="2"/></Row><Row Size="70"><Cell CellType="0" BackStyle="0" 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LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control></ListControls><ListControls Type="1"><Control Type="Control.Label" Name="글상자2" Visible="0" X1="50" Y1="450" Width="1900" Height="1100" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="1,2,10. &quot;최소한의 위험&quot; 이란 피험자가 임상연구에 참여함으로써 처할 수 있는 위험이나 불편의 가능성 및 그 정도가 정상인 기준의
    23. 

  23.          일상생활 혹은 일상적 검사에서 처하는 위험이나 불편에 비해 크지 않은 경우를 말함.
    24. 

  24. 

  25. 3. 참조: OHRP 는 정맥천자(venipuncture)의 경우 관혈적인(indwelling venous)  혈액의 채취에 대해 숙고함.
    26. 

  26. 

  27. 4,5. 참조: OHRP 는 하나의 관혈적인 라인으로부터 혈액을 여러 번 채취하는 것에 대해 숙고함. 그러므로 1주 내에 2회를 초과하는
    28. 

  28.       혈액 검체 채취를 포함하는 연구는 신속심사로 심의하는 것이 적당하지 않음
    29. 

  29. 

  30. 6. 예: (a) 비 손상적인 방법으로 잘라낸 머리카락, 손톱; (b) 박리시기의 유치 또는 일상적인 환자 치료를 위해 발치 된 유치; 
    31. 

  31.         (c) 일상적인 환자 치료를 위해 발치 된 영구치; (d) 배설물과 피부 분비물(땀 포함); (e) 관을 삽입하지 않고 분비자극 없이
    32. 

  32.         또는 껌을 씹거나 왁스 희석된 구연산 용액으로 혀를 자극하여 채취된 타액; (f) 분만 시 폐기되는 태반; (g) 출산 이전이나 
    33. 

  33.         도중에 막의 파열로 얻어지는 양수; (h) 일상적 예방목적의 스케일링보다 더 침습적이지 않은 과정이나 허용된 예방적 기술에
    34. 

  34.         따른 과정에 의해 채취된 잇몸 상부나 하부의 치석과 치태; (i) 구강을 문지르거나 닦아내는 방법 또는 피부를 닦아냄 또는 입을
    35. 

  35.         씻어내는 방법으로 채취된 점막과 피부 세포; (j) 생리식염수를 분무하여 채취된 객담
    36. 

  36. 

  37. 7. 예: (a) 체표면이나 거리를 두고 설치된 물리적인 센서로서 피험자에게 상당한 양의 에너지를 가하지 않거나 피험자의 사생활을
    38. 

  38.    침해하지 않는 경우; (b) 감각의 예민함을 평가하거나 시험하는 경우; (c) 자기공명영상(magnetic resonance imaging, MRI);
    39. 

  39.    (d) 심전도, 뇌파측정, 열측정, 자연방사능 측정, 전기망막검사, 초음파, 진단용 적외선 영상, 도플러 혈류측정기, 
    40. 

  40.    심장에코(echocardiography); (e) 개인의 나이, 체중,건강상태에 따른 적절한 중등도 운동, 근력검사, 신체 성분 검사, 유연성 검사
    41. 

  41. 

  42. 8. 예: perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, social behavior 에 
    43. 

  43.    관한 연구, 또는 employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, 
    44. 

  44.    quality assurance methodologies 에 관한 연구
    45. 

  45. 

  46. 9. 참조: 피험자들과의 상호작용만으로 제한됨. 이 범주 내에서는 비록 최소한의 위험일지라도 연구의 질을 향상시키기 위한 연구 관련
    47. 

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