서식 1-06_참관 확인서.rex 59 KB

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  3. 교육받고 다음 임상연구심의위원회의를
  4. 참관하였음을 확인합니다
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  6. &lt;제 차 임상연구심의위원회의&gt;
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  147. UUAf/9k=]]></Control></ListControls><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="512" Name="서브리포트섹션2" 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="99" 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="2700" 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="글상자13" Visible="0" X1="50" Y1="50" Width="1900" Height="100" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="1" Text="(별첨) 신규위원의 회의참관전 숙지사항 " MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕" FontSize="12" 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="글상자14" Visible="0" X1="50" Y1="160" Width="1900" Height="40" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" Text="* 책임심의위원의 발표" 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="글상자15" Visible="0" X1="50" Y1="250" Width="1900" Height="500" 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) 연구 개요 설명:
  148. 임상연구계획서제목/접수과/시험책임자/연구의 종류/단계(허가용/연구용,Phase)
  149. 연구대상: 의약품[세포치료제,유전자치료제]/의료기기/건강기능식품 등
  150. 2) 임상연구의 목적, 방법, 대상군 등을 간략히 설명함.
  151. 3) 미리 작성해 온'연구 계획서체크리스트'와 '피험자동의 체크리스트'등을 통하여 피험자가 얻을 수
  152. 있는 이익 및 위험과 위험을 최소화할 수 있는 방안 등 자신의 심의 의견을 먼저 발표함.
  153. 4) 연구의 위험에 비추어 결정한'중간보고/지속심의'주기에 대한 의견을 발표함.
  154. " 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. &quot;상임위원&quot;은 정규심의의 원활한 진행을 위하여 정규심의에 항시 참석하여 의견을
  155. 제출하는 위원으로서 약리학 전문가, 통계 전문가, 윤리 전문가와 기관과 관계가 없는
  156. 비전문가로 구성 한다. 전문적인 심의를 위하여 자주 심의되는 계획서의 종류에 따라 2명
  157. 이상의 임상전문의를 포함시킨다. 정규심의에 제출된 모든 연구계획서에 대하여 담당
  158. 분야를 사전검토 해야 한다. 참석이 불가한 경우에는 서면으로 의견을 제출해야 하며, 그
  159. 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
  160. 심의 내용을 전문간사에게 전달하고, 정규심의에서 발표하는 위원을 말한다.
  161. 2. 책임심의위원이 정규심의에서 발표할 때는 연구자의 교육이수 사항 및 연구팀의 적절한
  162. 연구능력 보유 등 '연구계획서체크리스트'에 있는 사항들을 중심으로 발표한다.
  163. " 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
  164. 회의가 개최될 수 있다.
  165. 2) 의약품 및 기타 심의 회의는 월 2회 (매월 제2주 화요일, 제4주 수요일) 개최하고,
  166. 생명윤리심의위원회와 의료기기심의위원회는 월 1회 개최한다.
  167. 3) 회의자료는 적절한 심의를 위해 정규심의 개최 적어도 일주일 전에 심의위원들 에게
  168. 배부되어야 한다.
  169. 4) 정규심의회의 전에 접수된 연구계획서의 심의를 원활히 진행하기 위하여 책임심의위원
  170. 제도와 상임위원제도를 둔다.
  171. 5) 제출된 초기 연구계획서는 책임심의위원을 배정하며, 책임심의위원은 정규심의에서
  172. 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.
  173. 6) 나머지 심의위원들은 피험자 동의서 사본과 동의서에 있는 연구 내용의 적절성을 판단할
  174. 수 있는 정도로 충분히 자세하게 기술된 계획서 요약본을 받는다.
  175. 7) 행정간사는 과제별 연구책임자가 현재 진행중인 과제의 수를 확인하여 심의 첨부자료로
  176. 제시한다. 이 내용은 연구책임자의 현재 연구수행 능력에 대한 심의에 반영되도록 한다.
  177. 8) 정규심의에서 계획서, 재심의 보완서류, 결과보고서 심의의 판정에 대해 책임심의위원의
  178. 의견을 종합하여, 출석한 심의위원들의 투표에 의해 과반수 이상의 의견으로 심의
  179. 결과를 판정한다.
  180. 9) 정규심의에서 모든 심의위원들은 제출된 모든 자료를 볼 수 있어야 한다.
  181. 10) 회의 시 모든 발표는 비전문가도 쉽게 이해할 수 있는 언어로 설명한다.
  182. 11) 위원회에 출석한 심의위원은 위원회에 접수된 모든 계획서를 심의한다. 단 신속심의
  183. 요건에 해당하는 건은 추인하는 것을 원칙으로 한다.
  184. 12) 연구책임자가 위원회 위원인 경우 해당 연구의 심의에는 참여할 수 없다
  185. 13) 위원회는 필요 시 관련 전문가를 자문위원으로 위촉하여 의견을 들을 수 있으나
  186. 자문위원은 심의에 참여할 수 없다
  187. 14) 위원회는 연구책임자에게 연구에 관한 구두 설명, 보충 자료의 제출을 요구할 수 있다.
  188. 15) 정족수 및 찬반 투표 결과는 매 안건 심의마다 확인되고 회의록에 기록한다.
  189. 16) 모든 계획서의 위원회 승인은 별도의 위원회 결정이 없는 한 1년간 유효하다.
  190. 17) 연구책임자는 연구계획의 초기 심의, 연구진행과정에서 발생한 문제에 대한
  191. 심의과정에서 위원회가 출석을 요구할 때는 반드시 참석하여야 한다.
  192. 18) 위원장은 연구자 및 의뢰자와 관련이 없는 위원에 한하여 심의과정에 참여하게 하거나
  193. 의견을 제시할 수 있도록 하여야 한다.
  194. 19) 위원장은 연구책임자가 위원회의 위원에게 영향을 미치거나 해당 연구와 관련된 사항의
  195. 결정과정에 참여할 수 없도록 하여야 한다.
  196. 20) 위원장은 위원회에 출석한 위원에게 심의할 연구과제와 이해갈등의 관계가 있는지
  197. 물어보고 관계가 있는 위원은 퇴장토록 한다.
  198. 21) 연구책임자가 심의되는 내용에 대해 직접 소명하고자 할 때에는 위원회에 그 의사를
  199. 전달할 수 있으며, 위원회는 그 사유가 적절하다고 판단될 때에 위원회 출석을 허용할
  200. 수 있다.
  201. 22) 임상시험 계획서 심의 시 식약청 승인 대상여부를 반드시 확인해야 한다
  202. " 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
  203. 2) 시작기도
  204. 3) 의사정족수 확인
  205. 4) 심의 위원들과 심의할 임상연구 사이의 이해갈등 여부 확인
  206. 5) 지난 회의록 검토 및 승인(단, 같은 팀의 회의에 대한 회의록)
  207. 6) 지난 정규심의 이후 시행된 신속심의 내용 보고
  208. 7) 초기계획서의 신속심의 (제목, 시험책임자)
  209. 8) 보완답변서의 신속심의 (제목, 시험책임자)
  210. " 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)
  211. 10) 종료보고서의 신속심의 (제목, 시험책임자)
  212. 11) 중대한이상반응 보고 신속심의 (세부사항 요약)
  213. 12) 연구계획서 심의(시험책임자의 현재진행중인 임상시험계획서수와 진행인력여건 함께 심의), 토론, 투표
  214. 13) 지속심의신청서의 심의(시험책임자의 현재진행중인 임상시험계획서수와 진행인력여건 함께 심의), 토론, 투표
  215. 14) 결과보고서의 심의, 토론, 투표
  216. 15) 기타안건 논의 또는 결정
  217. 16) 마침 기도
  218. 17) 폐회 선언
  219. " 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.
  220. 2) 연구 활동이 심의되는 모든 회의에는 기관 외부의 인사 및 비전문가(법률가 또는
  221. 종교인, 윤리전문가 등)가 반드시 참석하여야만 한다.
  222. 3) 약품이나 생물학 제재, 의료기기 등을 다루는 연구 활동의 심의에는 의사가 최소한 한
  223. 사람은 반드시 참석하여야만 하다.
  224. 4) 위원만이 투표할 수 있다.
  225. 5) 현재 심의하고 있는 안건과 이해갈등관계가 있는 위원은 투표할 수 없다.
  226. 6) 연구를 승인하기 위해서는 출석 위원 중 과반수의 위원들이 찬성하여야 한다.
  227. 대리투표는 인정하지 않는다.
  228. 7) 필요하다면 전화 또는 화상회의 등을 통해 회의를 진행할 수 있다. 이를 위해서는 회의
  229. 이전에 모든 위원들이 적절한 자료를 제공받아야 하며, 참석한 경우와 동일하게
  230. 적극적으로 회의를 진행할 수 있어야 한다. 이러한 회의의 경우, 회의록에는 여타 법규가
  231. 요구하는 조건 이외에도 위의 두 가지 조건이 충족되었음이 분명하게 기록되어야 한다.
  232. 8) 정족수는 매 안건에 대한 심의마다 확인되고 회의록에 기록되어야 한다. (찬반투표
  233. 결과(예: 총인원-10; 찬성-8, 반대-1, 기권-1), 부결 또는 수정 요구의 근거, 승인
  234. 기간(심의 간격)에 대한 결정 사항)
  235. 9) 연구가 승인되면 위원회는 각 연구의 중간보고 주기를 결정한다.
  236. " 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)
  237. 2) 조건부로 승인한다 (조건부 승인):
  238. 위원회가 요구한 대로 시정되면 행정간사의 확인을 거쳐 승인한다.
  239. 3) 자료보완이 요구됨 (시정 승인):
  240. 일정한 결정사항에 대해 수정 내지 추가 자료를 요구하며, 신속심의 한다.
  241. 4) 재검토가 요구된다 (보완 후 재심)
  242. 일정한 결정사항에 대해 수정 내지 추가자료를 요구하며 정규심의 한다.
  243. 5) 승인치 않는다 (반려)
  244. 6) 승인된 임상시험을 중지 또는 보류한다 (중지/보류)
  245. " 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="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><Section Type="8" Name="페이지바닥글" 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>