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PRIIA00116_심의결과통보서.rex

PRIIA00116_심의결과통보서.rex 385 KB
永久链接 文件历史 原始文件

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  1. <?xml version="1.0"?>
    2. 

  2. <Report Title="" Author="" Company="" Category="" Description="" CreatedDate="2008-04-04 16:29:34" LastSavedDate="2009-05-08 10:34:26" Version="2.5.1.78"><FieldInfo><FieldSet ID="1"><Field Name="judgappdg" Type="8" Size="0" Xpath="../judgappdg"/><Field Name="judgdd" Type="8" Size="0" Xpath="../judgdd"/><Field Name="judgweek" Type="8" Size="0" Xpath="../judgweek"/><Field Name="conftm" Type="8" Size="0" Xpath="../conftm"/><Field Name="confplc" Type="8" Size="0" Xpath="../confplc"/><Field Name="judgrslt" Type="8" Size="0" Xpath="../judgrslt"/><Field Name="judgitem1" Type="8" Size="0" Xpath="../judgitem1"/><Field Name="subjno" Type="8" Size="0" Xpath="../subjno"/><Field Name="itemnm" Type="8" Size="0" Xpath="../itemnm"/><Field Name="comnm" Type="8" Size="0" Xpath="../comnm"/><Field Name="respstdynm" Type="8" Size="0" Xpath="../respstdynm"/><Field Name="subjnm" Type="8" Size="0" Xpath="../subjnm"/><Field Name="stdykind4" Type="8" Size="0" Xpath="../stdykind4"/><Field Name="verplan" Type="8" Size="0" Xpath="../verplan"/><Field Name="veraprv" Type="8" Size="0" Xpath="../veraprv"/><Field Name="vercrf" Type="8" Size="0" Xpath="../vercrf"/><Field Name="verib" Type="8" Size="0" Xpath="../verib"/><Field Name="allentry" Type="8" Size="0" Xpath="../allentry"/><Field Name="etctrgt4" Type="8" Size="0" Xpath="../etctrgt4"/><Field Name="hospcd" Type="8" Size="0" Xpath="../hospcd"/><Field Name="hospnm" Type="8" Size="0" Xpath="../hospnm"/><Field Name="zipcd1" Type="8" Size="0" Xpath="../zipcd1"/><Field Name="zipcd2" Type="8" Size="0" Xpath="../zipcd2"/><Field Name="addr" Type="8" Size="0" Xpath="../addr"/><Field Name="telno" Type="8" Size="0" Xpath="../telno"/><Field Name="faxno" Type="8" Size="0" Xpath="../faxno"/><Field Name="cmpynm" Type="8" Size="0" Xpath="../cmpynm"/><Field Name="nm" Type="8" Size="0" Xpath="../nm"/><Field Name="stdykind1" Type="8" Size="0" Xpath="../stdykind1"/><Field Name="reptkind" Type="8" Size="0" Xpath="../reptkind"/><Field Name="irbzipcd1" Type="8" Size="0" Xpath="../irbzipcd1"/><Field Name="irbzipcd2" Type="8" Size="0" Xpath="../irbzipcd2"/><Field Name="irbaddr" Type="8" Size="0" Xpath="../irbaddr"/><Field Name="irbmngertelno" Type="8" Size="0" Xpath="../irbmngertelno"/><Field Name="irbmngernm" Type="8" Size="0" Xpath="../irbmngernm"/><Field Name="irbmngerfaxno" Type="8" Size="0" Xpath="../irbmngerfaxno"/><Field Name="deptnm" Type="8" Size="0" Xpath="../deptnm"/><Field Name="data" Type="8" Size="0" Xpath="data"/><Field Name="iisdversion" Type="8" Size="0" Xpath="../iisdversion"/><Field Name="head1" Type="8" Size="0" Xpath="../head1"/><Field Name="consorflag" Type="8" Size="0" Xpath="../consorflag"/><Field Name="img1" Type="8" Size="0" Xpath="../img1"/><Field Name="img2" Type="8" Size="0" Xpath="../img2"/><Field Name="docno" Type="8" Size="0" Xpath="../docno"/><Field Name="judgnms" Type="8" Size="0" Xpath="../judgnms"/></FieldSet><FieldSet ID="2"/><FieldSet ID="3"><Field Name="judgnm" ScriptType="1"><![CDATA[if ("{@judgrslt}" =="Y"){
    3. 

  3.  return "승인";
    4. 

  4. } 
    5. 

  5. else if ("{@judgrslt}" =="A"){
    6. 

  6.  return "시정승인";
    7. 

  7. }
    8. 

  8. else if ("{@judgrslt}" =="R"){
    9. 

  9.  return "반려";
    10. 

  10. }
    11. 

  11. else if ("{@judgrslt}" =="V"){
    12. 

  12.  return "보완후재심";
    13. 

  13. }
    14. 

  14. else if ("{@judgrslt}" =="S"){
    15. 

  15.  return "저장";
    16. 

  16. } 
    17. 

  17. else if ("{@judgrslt}" =="B"){
    18. 

  18.  return "부결";
    19. 

  19. }
    20. 

  20. else if ("{@judgrslt}" =="N"){
    21. 

  21.  return "승인된시험중지";
    22. 

  22. }
    23. 

  23. ]]></Field><Field Name="stdynm" ScriptType="1"><![CDATA[if ("{@stdykind4}" =="F"){
    24. 

  24.  return "1상";
    25. 

  25. } 
    26. 

  26. else if ("{@stdykind4}" =="S"){
    27. 

  27.  return "2상";
    28. 

  28. }
    29. 

  29. else if ("{@stdykind4}" =="T"){
    30. 

  30.  return "3상";
    31. 

  31. }
    32. 

  32. 

  33. else if ("{@stdykind4}" =="Y"){
    34. 

  34.  return "4상";
    35. 

  35. }
    36. 

  36. 

  37. else if ("{@stdykind4}" =="I"){
    38. 

  38.  return "학술연구";
    39. 

  39. }
    40. 

  40. 

  41. else if ("{@stdykind4}" =="P"){
    42. 

  42.  return "PK연구";
    43. 

  43. }
    44. 

  44. 

  45. else if ("{@stdykind4}" =="E"){
    46. 

  46.  return "기타";
    47. 

  47. }
    48. 

  48. ]]></Field><Field Name="reptnm" ScriptType="1"><![CDATA[if ("{@reptkind}" =="1"){
    49. 

  49.  return "보완답변서";
    50. 

  50. } 
    51. 

  51. else if ("{@reptkind}" =="2"){
    52. 

  52.  return "중간보고서";
    53. 

  53. }
    54. 

  54. else if ("{@reptkind}" =="3"){
    55. 

  55.  return "SAE(원내)";
    56. 

  56. }
    57. 

  57. 

  58. else if ("{@reptkind}" =="4"){
    59. 

  59.  return "SAE(원외)";
    60. 

  60. }
    61. 

  61. 

  62. else if ("{@reptkind}" =="5"){
    63. 

  63.  return "변경계획서";
    64. 

  64. }
    65. 

  65. 

  66. else if ("{@reptkind}" =="6"){
    67. 

  67.  return "종료보고서";
    68. 

  68. }
    69. 

  69. 

  70. else if ("{@reptkind}" =="7"){
    71. 

  71.  return "결과보고서";
    72. 

  72. }
    73. 

  73. else if ("{@reptkind}" =="8"){
    74. 

  74.  return "지속심의";
    75. 

  75. }
    76. 

  76. else if ("{@reptkind}" =="9"){
    77. 

  77.  return "계획서";
    78. 

  78. }
    79. 

  79. 

  80. ]]></Field><Field Name="stdykind1" ScriptType="1"><![CDATA[if ( "{@stdykind1}" == "M"){
    81. 

  81.  return "의약품";
    82. 

  82. } 
    83. 

  83. else if ( "{@stdykind1}" == "D"){
    84. 

  84.  return "의료기기";
    85. 

  85. } 
    86. 

  86. else if ( "{@stdykind1}" == "B"){
    87. 

  87.  return "생물학적제제";
    88. 

  88. } 
    89. 

  89. else if ( "{@stdykind1}" == "C"){
    90. 

  90.  return "세포치료제";
    91. 

  91. } 
    92. 

  92. else if ( "{@stdykind1}" == "H"){
    93. 

  93.  return "건강식품";
    94. 

  94. } 
    95. 

  95. else if ( "{@stdykind1}" == "R"){
    96. 

  96.  return "의무기록이용연구";
    97. 

  97. } 
    98. 

  98. else if ( "{@stdykind1}" == "O"){
    99. 

  99.  return "관찰연구";
    100. 

  100. } 
    101. 

  101. else if ( "{@stdykind1}" == "S"){
    102. 

  102.  return "보관검체이용연구";
    103. 

  103. } 
    104. 

  104. else if ( "{@stdykind1}" == "T"){
    105. 

  105.  return "시료연구 (조직 및 혈액)";
    106. 

  106. } 
    107. 

  107. else if ( "{@stdykind1}" == "P"){
    108. 

  108.  return "생동성연구";
    109. 

  109. } 
    110. 

  110. else if ( "{@stdykind1}" == "E"){
    111. 

  111.  return "기타";
    112. 

  112. } ]]></Field><Field Name="judgappdg" ScriptType="1"><![CDATA[return "( " + "{@judgappdg}" + " 차)"]]></Field><Field Name="judgdd" ScriptType="1"><![CDATA[return "{@judgdd}".substr(0, 4) + "-" + "{@judgdd}".substr(4, 2) + "-" + "{@judgdd}".substr(6, 2) + "      ( " + "{@judgappdg}" + " 차)"]]></Field></FieldSet><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="2" DataPath="D:\CMCOracle\application\webapps\crc\irbsubweb\rex\PRIIA00116.xml" DataRoot="root/main/rexjudgconf/item/datainfo" XslPath="" XsdPath="" CsvPath="" CsvRowSeparator="" CsvColumnSeparator=""><OrderInfos><OrderInfo ID="0" Method="0" GrpSectionIndex="2" OrderingFieldID="1" OrderingFieldIndex="43"><SpecifiedOrderInfo OtherTypesType="1" OtherTypesText=""/></OrderInfo><OrderInfo ID="0" Method="0" GrpSectionIndex="3" OrderingFieldID="1" OrderingFieldIndex="7"><SpecifiedOrderInfo OtherTypesType="1" OtherTypesText=""/></OrderInfo></OrderInfos><FilterInfos/><SPInfo FunctionName=""/><SQL></SQL><ServerConnection URL="" DataType=""/></DataSetting><GlobalStyleManager><GlobalStyle Name="stdykind1M"><PropertySetting Name="Text" Value="의약품"/></GlobalStyle><GlobalStyle Name="stdykind1D"><PropertySetting Name="Text" Value="의료기기"/></GlobalStyle><GlobalStyle Name="stdykind1B"><PropertySetting Name="Text" Value="생물학적제제"/></GlobalStyle><GlobalStyle Name="stdykind1C"><PropertySetting Name="Text" Value="세포치료제"/></GlobalStyle><GlobalStyle Name="stdykind1H"><PropertySetting Name="Text" Value="건강식품"/></GlobalStyle><GlobalStyle Name="stdykind1R"><PropertySetting Name="Text" Value="의무기록 이용연구"/></GlobalStyle><GlobalStyle Name="stdykind1O"><PropertySetting Name="Text" Value="관찰연구"/></GlobalStyle><GlobalStyle Name="stdykind1S"><PropertySetting Name="Text" Value="보관검체 이용연구"/></GlobalStyle><GlobalStyle Name="stdykind1T"><PropertySetting Name="Text" Value="시료연구(조직 및 혈액 등)"/></GlobalStyle><GlobalStyle Name="stdykind1P"><PropertySetting Name="Text" Value="생동성연구"/></GlobalStyle><GlobalStyle Name="stdykind1E"><PropertySetting Name="Text" Value="기타"/></GlobalStyle><GlobalStyle Name="stdykindEtc"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="stdykind4Etc"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="stdykind1EtcN"><PropertySetting Name="Visible" Value="3"/></GlobalStyle><GlobalStyle Name="stdykind4EtcN"><PropertySetting Name="Visible" Value="3"/></GlobalStyle><GlobalStyle Name="stdykind4F"><PropertySetting Name="Text" Value="1상"/></GlobalStyle><GlobalStyle Name="stdykind4S"><PropertySetting Name="Text" Value="2상"/></GlobalStyle><GlobalStyle Name="stdykind4T"><PropertySetting Name="Text" Value="3상"/></GlobalStyle><GlobalStyle Name="stdykind4V"><PropertySetting Name="Text" Value="4상"/></GlobalStyle><GlobalStyle Name="stdykind4I"><PropertySetting Name="Text" Value="학술연구"/></GlobalStyle><GlobalStyle Name="stdykind4P"><PropertySetting Name="Text" Value="PK연구"/></GlobalStyle><GlobalStyle Name="stdykind4E"><PropertySetting Name="Text" Value="기타"/></GlobalStyle><GlobalStyle Name="irbjudgflagY"><PropertySetting Name="Text" Value="승인"/></GlobalStyle><GlobalStyle Name="irbjudgflagA"><PropertySetting Name="Text" Value="시정승인"/></GlobalStyle><GlobalStyle Name="irbjudgflagR"><PropertySetting Name="Text" Value="반려"/></GlobalStyle><GlobalStyle Name="irbjudgflagV"><PropertySetting Name="Text" Value="보완 후 재심"/></GlobalStyle><GlobalStyle Name="irbjudgflagS"><PropertySetting Name="Text" Value="저장"/></GlobalStyle><GlobalStyle Name="irbjudgflagB"><PropertySetting Name="Text" Value="부결"/></GlobalStyle><GlobalStyle Name="irbjudgflagN"><PropertySetting Name="Text" Value="승인된 시험 중지"/></GlobalStyle><GlobalStyle Name="visible"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="hidden"><PropertySetting Name="Visible" Value="3"/></GlobalStyle></GlobalStyleManager><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="100" LeftMargin="50" BottomMargin="100" RightMargin="50"/><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="100" LeftMargin="50" BottomMargin="100" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="50" 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="4" Name="페이지머리글" Height="250" 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" 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="글상자2" Visible="0" X1="450" Y1="160" Width="1100" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" Text=" 임상연구심의위원회(  CMC IRB) / 기관생명윤리심의위원회" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="9" 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.Field" Name="필드5" Visible="0" X1="280" Y1="160" Width="300" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="2" VerticalAlignment="1" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" CanGrow="0" CanShrink="0" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" SummaryFunction="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="9" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" Text="@hospnm" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" FieldID="1" FieldIndex="20"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Field" Name="필드6" Visible="0" X1="834" Y1="160" Width="70" Height="50" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="2" VerticalAlignment="1" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" CanGrow="0" CanShrink="0" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" SummaryFunction="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="굴림" FontSize="9" FontBold="0" FontUnderline="0" FontItalic="0" FontStrike="0" ForeColor="0" Text="@hospcd" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" FieldID="1" FieldIndex="19"><FieldReferences/><SummaryCondition/><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="16" Name="그룹머리글3" Height="50" 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" 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    113. 

  113.   return "보완답변서";
    114. 

  114. }
    115. 

  115. if ( "{@reptkind}" == "6" ) {
    116. 

  116.   return "종료보고서";
    117. 

  117. }
    118. 

  118. if ( "{@reptkind}" == "7" ) {
    119. 

  119.   return "결과보고서";
    120. 

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GroupFieldID="-1" GroupFieldIndex="-1" GroupSortingFieldID="-1" GroupSortingFieldIndex="-1" GroupTOCFieldID="-1" GroupTOCFieldIndex="-1"><ListControls Type="0"/><ListControls Type="1"><Control Type="Control.Image" Name="그림5" Visible="0" X1="1410" Y1="280" Width="316" Height="260" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" SizeMode="5" SourceType="1" Embedding="0" Path="" Frame="0" ImageFormat="1" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0" DataFieldID="1" DataFieldIndex="41"><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/></Control><Control Type="Control.Table" Name="표2" Visible="0" X1="50" Y1="0" Width="1900" Height="450" FitSection="0" LinkIndex="27" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="0" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="1" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0.75" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="330"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="* 귀하가 신청하신 심의안건에 대하여 본임상연구심의위원회의 심의결과를 위와 같이 알려드립니다
    121. 

  121. * 만약 본위원회의 심사판정에 불복할 경우 심사결과 통보 후 2주일 이내 그 사유를 기록하여 본 위원회로 제출하여 
    122. 

  122.    주십시오.
    123. 

  123. * 본 임상연구심의위원회는 KGCP 및 ICH-GCP 규정을 준수하며, 생명윤리 및 안전에관한 법률 등 관련 법규를 준수
    124. 

  124.    합니다.
    125. 

  125. * 임상시험 문서보관 기한은 10년이며 그 이상 보관을 요청할 경우에는 비용 등 관련절차를 담당자와 상의하시기 바
    126. 

  126.    랍니다." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="2" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="30" 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="1"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="120"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="가톨릭대학교                   병원장  (직인)" MultiLine="1" WordWrap="1" WordSpace="0" 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    127. 

  127.  return "승인";
    128. 

  128. } 
    129. 

  129. else if ("{@judgrslt}" =="A"){
    130. 

  130.  return "시정승인";
    131. 

  131. }
    132. 

  132. else if ("{@judgrslt}" =="R"){
    133. 

  133.  return "반려";
    134. 

  134. }
    135. 

  135. else if ("{@judgrslt}" =="V"){
    136. 

  136.  return "보완후재심";
    137. 

  137. }
    138. 

  138. else if ("{@judgrslt}" =="S"){
    139. 

  139.  return "저장";
    140. 

  140. } 
    141. 

  141. else if ("{@judgrslt}" =="B"){
    142. 

  142.  return "부결";
    143. 

  143. }
    144. 

  144. else if ("{@judgrslt}" =="N"){
    145. 

  145.  return "승인된시험중지";
    146. 

  146. }
    147. 

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    148. 

  148.  return "1상";
    149. 

  149. } 
    150. 

  150. else if ("{@stdykind4}" =="S"){
    151. 

  151.  return "2상";
    152. 

  152. }
    153. 

  153. else if ("{@stdykind4}" =="T"){
    154. 

  154.  return "3상";
    155. 

  155. }
    156. 

  156. 

  157. else if ("{@stdykind4}" =="Y"){
    158. 

  158.  return "4상";
    159. 

  159. }
    160. 

  160. 

  161. else if ("{@stdykind4}" =="I"){
    162. 

  162.  return "학술연구";
    163. 

  163. }
    164. 

  164. 

  165. else if ("{@stdykind4}" =="P"){
    166. 

  166.  return "PK연구";
    167. 

  167. }
    168. 

  168. 

  169. else if ("{@stdykind4}" =="E"){
    170. 

  170.  return "기타";
    171. 

  171. }
    172. 

  172. ]]></Field><Field Name="reptnm" ScriptType="1"><![CDATA[if ("{@reptkind}" =="1"){
    173. 

  173.  return "보완답변서";
    174. 

  174. } 
    175. 

  175. else if ("{@reptkind}" =="2"){
    176. 

  176.  return "중간보고서";
    177. 

  177. }
    178. 

  178. else if ("{@reptkind}" =="3"){
    179. 

  179.  return "SAE(원내)";
    180. 

  180. }
    181. 

  181. 

  182. else if ("{@reptkind}" =="4"){
    183. 

  183.  return "SAE(원외)";
    184. 

  184. }
    185. 

  185. 

  186. else if ("{@reptkind}" =="5"){
    187. 

  187.  return "변경계획서";
    188. 

  188. }
    189. 

  189. 

  190. else if ("{@reptkind}" =="6"){
    191. 

  191.  return "종료보고서";
    192. 

  192. }
    193. 

  193. 

  194. else if ("{@reptkind}" =="7"){
    195. 

  195.  return "결과보고서";
    196. 

  196. }
    197. 

  197. else if ("{@reptkind}" =="8"){
    198. 

  198.  return "지속심의";
    199. 

  199. }
    200. 

  200. else if ("{@reptkind}" =="9"){
    201. 

  201.  return "계획서";
    202. 

  202. }
    203. 

  203. 

  204. ]]></Field><Field Name="stdykind1" ScriptType="1"><![CDATA[if ( "{@stdykind1}" == "M"){
    205. 

  205.  return "의약품";
    206. 

  206. } 
    207. 

  207. else if ( "{@stdykind1}" == "D"){
    208. 

  208.  return "의료기기";
    209. 

  209. } 
    210. 

  210. else if ( "{@stdykind1}" == "B"){
    211. 

  211.  return "생물학적제제";
    212. 

  212. } 
    213. 

  213. else if ( "{@stdykind1}" == "C"){
    214. 

  214.  return "세포치료제";
    215. 

  215. } 
    216. 

  216. else if ( "{@stdykind1}" == "H"){
    217. 

  217.  return "건강식품";
    218. 

  218. } 
    219. 

  219. else if ( "{@stdykind1}" == "R"){
    220. 

  220.  return "의무기록이용연구";
    221. 

  221. } 
    222. 

  222. else if ( "{@stdykind1}" == "O"){
    223. 

  223.  return "관찰연구";
    224. 

  224. } 
    225. 

  225. else if ( "{@stdykind1}" == "S"){
    226. 

  226.  return "보관검체이용연구";
    227. 

  227. } 
    228. 

  228. else if ( "{@stdykind1}" == "T"){
    229. 

  229.  return "시료연구 (조직 및 혈액)";
    230. 

  230. } 
    231. 

  231. else if ( "{@stdykind1}" == "P"){
    232. 

  232.  return "생동성연구";
    233. 

  233. } 
    234. 

  234. else if ( "{@stdykind1}" == "E"){
    235. 

  235.  return "기타";
    236. 

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SecondItemFieldAdjustCrosstabRowColumnIndex="-1"/></ConditionalStyle></ConditionalStyles><Report Title="" Author="" Company="" Category="" Description="" CreatedDate="" LastSavedDate="" Version=""><FieldInfo><FieldSet ID="1"><Field Name="data" Type="8" Size="0" Xpath="data"/><Field Name="reptkind" Type="8" Size="0" Xpath="../reptkind"/><Field Name="reptnm" Type="8" Size="0" Xpath="../reptnm"/><Field Name="reptseqno" Type="8" Size="0" Xpath="../reptseqno"/><Field Name="subjno" Type="8" Size="0" Xpath="../subjno"/><Field Name="subjnm" Type="8" Size="0" Xpath="../subjnm"/><Field Name="respstdyempnm" Type="8" Size="0" Xpath="../respstdyempnm"/><Field Name="conftm" Type="8" Size="0" Xpath="../conftm"/><Field Name="confplc" Type="8" Size="0" Xpath="../confplc"/><Field Name="cmpynm" Type="8" Size="0" Xpath="../cmpynm"/><Field Name="stdykind" Type="8" Size="0" Xpath="../stdykind"/><Field Name="judgentrylist" Type="8" Size="0" Xpath="../judgentrylist"/><Field Name="cnts1" Type="8" Size="0" Xpath="../cnts1"/><Field Name="cnts2" Type="8" Size="0" Xpath="../cnts2"/><Field Name="cnts3" Type="8" Size="0" Xpath="../cnts3"/><Field Name="cnts4" Type="8" Size="0" Xpath="../cnts4"/><Field Name="cnts5" Type="8" Size="0" Xpath="../cnts5"/><Field Name="cnts6" Type="8" Size="0" Xpath="../cnts6"/><Field Name="cnts7" Type="8" Size="0" Xpath="../cnts7"/><Field Name="cnts8" Type="8" Size="0" Xpath="../cnts8"/><Field Name="cnts9" Type="8" Size="0" Xpath="../cnts9"/><Field Name="cnts10" Type="8" Size="0" Xpath="../cnts10"/><Field Name="cnts11" Type="8" Size="0" Xpath="../cnts11"/><Field Name="cnts12" Type="8" Size="0" Xpath="../cnts12"/><Field Name="cnts13" Type="8" Size="0" Xpath="../cnts13"/><Field Name="cnts14" Type="8" Size="0" Xpath="../cnts14"/><Field Name="cnts15" Type="8" Size="0" Xpath="../cnts15"/><Field Name="judgrslt" Type="8" Size="0" Xpath="../judgrslt"/><Field Name="judgitem1" Type="8" Size="0" Xpath="../judgitem1"/><Field Name="judgitem2" Type="8" Size="0" Xpath="../judgitem2"/><Field Name="judgitem3" Type="8" Size="0" Xpath="../judgitem3"/><Field Name="judgitem4" Type="8" Size="0" Xpath="../judgitem4"/><Field Name="judgitem5" Type="8" Size="0" Xpath="../judgitem5"/><Field Name="judgitem6" Type="8" Size="0" Xpath="../judgitem6"/><Field Name="judgitem7" Type="8" Size="0" Xpath="../judgitem7"/><Field Name="judgitem8" Type="8" Size="0" Xpath="../judgitem8"/><Field Name="reptcls" Type="8" Size="0" Xpath="../reptcls"/><Field Name="trobreactcls" Type="8" Size="0" Xpath="../trobreactcls"/><Field Name="seffcgenrdd" Type="8" Size="0" Xpath="../seffcgenrdd"/><Field Name="reptdd" Type="8" Size="0" Xpath="../reptdd"/><Field Name="acptdd" Type="8" Size="0" Xpath="../acptdd"/><Field Name="irbcnfmdd" Type="8" Size="0" Xpath="../irbcnfmdd"/><Field Name="testeeid" Type="8" Size="0" Xpath="../testeeid"/><Field Name="testeenm" Type="8" Size="0" Xpath="../testeenm"/><Field Name="subtesteegndr" Type="8" Size="0" Xpath="../subtesteegndr"/><Field Name="subtesteeht" Type="8" Size="0" Xpath="../subtesteeht"/><Field Name="subtesteebdwt" Type="8" Size="0" Xpath="../subtesteebdwt"/><Field Name="subtesteebrthdd" Type="8" Size="0" Xpath="../subtesteebrthdd"/></FieldSet><FieldSet ID="2"/><FieldSet ID="3"><Field Name="reptkind" ScriptType="1"><![CDATA[if ( "{@reptkind}" == "1" ) {
    237. 

  237.   return "보완답변서";
    238. 

  238. }
    239. 

  239. if ( "{@reptkind}" == "6" ) {
    240. 

  240.   return "종료보고서";
    241. 

  241. }
    242. 

  242. if ( "{@reptkind}" == "7" ) {
    243. 

  243.   return "결과보고서";
    244. 

  244. }]]></Field></FieldSet><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="2" DataPath="D:\CMCOracle\application\webapps\crc\irbsubweb\rex\PRIIA00116.xml" DataRoot="root/main/rexrept/cnst/datainfo2" 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="100" LeftMargin="50" BottomMargin="100" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="100" Visible="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" CanGrow="0" 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RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="0" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="1" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0.75" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="330"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="* 귀하가 신청하신 심의안건에 대하여 본임상연구심의위원회의 심의결과를 위와 같이 알려드립니다
    245. 

  245. * 만약 본위원회의 심사판정에 불복할 경우 심사결과 통보 후 2주일 이내 그 사유를 기록하여 본 위원회로 제출하여 
    246. 

  246.    주십시오.
    247. 

  247. * 본 임상연구심의위원회는 KGCP 및 ICH-GCP 규정을 준수하며, 생명윤리 및 안전에관한 법률 등 관련 법규를 준수
    248. 

  248.    합니다.
    249. 

  249. * 임상시험 문서보관 기한은 10년이며 그 이상 보관을 요청할 경우에는 비용 등 관련절차를 담당자와 상의하시기 바
    250. 

  250.    랍니다." 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PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="100" LeftMargin="50" BottomMargin="100" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="50" 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" 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="1750" 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="글상자2" Visible="0" X1="75" Y1="0" Width="1850" Height="100" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" Text="연구자의 임상시험/연구 수행시 지켜야 할 사항" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕체" FontSize="16" 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="글상자3" Visible="0" X1="75" Y1="150" Width="1850" Height="1600" 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.  위원회의 승인을 받은 계획서에 따라 연구를 수행하십시오.
    251. 

  251. 2.  위원회의 승인을 받은 피험자 동의서를 사용하십시오.
    252. 

  252. 3.  모국어가 한국어가 아닌 피험자들에게는 승인된 동의서를 피험자의 모국어로 인증된 번역본을 
    253. 

  253.     사용할 것이며, 이러한 동의서 번역본은 반드시 위원회 승인을 받아야 합니다.
    254. 

  254. 4.  연구진행에 있어 피험자를 보호하기 위해 불가피한 경우를 제외하고 연구의 어떠한 변경이든 
    255. 

  255.     위원회의 사전 승인을 받고 수행하십시오. 피험자들의 보호를 위해 취해진 어떠한 응급상황에
    256. 

  256.     서의 변경도 즉각 위원회에 보고 해야합니다.
    257. 

  257. 5.  위원회에서 승인된 계획서에 따라 등록된 어떠한 피험자라도 사망, 입원, 심각한 부작용에 대
    258. 

  258.     하여는 위원회에 서면으로 보고해야 합니다.
    259. 

  259. 6.  임상시험 또는 피험자의 안전에 대해 유해한 영향을 미칠 수 있는 어떠한 새로운 정보도 즉각
    260. 

  260.     적으로 위원회에 보고해야 합니다.
    261. 

  261. 7.  위원회의 요구가 있을 때에는 연구의 진행과 관련된 보고를 위원회에 제출해 주시기 바랍니다.
    262. 

  262. 8.  피험자 모집광고는 사용 전에 위원회로부터 승인을 득한후 사용해야 합니다.
    263. 

  263. 9.  강제 혹은 부당한 영향이 없는 상태에서 충분한 설명에 근거한 동의 과정을 수행할 것이며, 잠
    264. 

  264.     재적인 피험자에게 연구에의 참여여부를 고려할 수 있도록 충분히 기회를 제공해야 합니다.  
    265. 

  265. 10. 위원회의 승인 후 연구를 개시하게 되면 적어도 연 1회 이상 중간보고서 를 지속심의신청서와 
    266. 

  266.     함께 제출하여야 합니다.
    267. 

  267. 11. 임상시험이 종료(조기종료를 포함한다)된 경우, 연구종료 요약자료와 함께 임상시험 종료 사실
    268. 

  268.     을 서식 21-02에 따라 위원회에 보고하여야 합니다. 
    269. 

  269. 12. 결과보고에 대한 내용 첨가는 연구 종료 1년 이내에 서식21-03을 작성하여 위원회에 제출해야 
    270. 

  270.     하고, 또한 연구 결과의 학술 논문 형식의 발표는 위원회의 승인 이후에만 가능하며, 논문에 본 
    271. 

  271.     위원회로부터 계획서에 대한 심의와 승인을 받았다는 사실을 명시해야 합니다. 결과보고서를 연
    272. 

  272.     구 종료 1년 이내에 제출하지 않은 연구책임자의 경우 이후 연구책임자로서 본 위원회에 계획서
    273. 

  273.     를 제출하는 것을 제한할 수 있습니다.
    274. 

  274. 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Size="0" Xpath="../deptnm"/><Field Name="data" Type="8" Size="0" Xpath="data"/><Field Name="iisdversion" Type="8" Size="0" Xpath="../iisdversion"/><Field Name="head1" Type="8" Size="0" Xpath="../head1"/><Field Name="docno" Type="8" Size="0" Xpath="../docno"/><Field Name="judgnms" Type="8" Size="0" Xpath="../judgnms"/></FieldSet><FieldSet ID="2"/><FieldSet ID="3"><Field Name="judgnm" ScriptType="1"><![CDATA[if ("{@judgrslt}" =="Y"){
    275. 

  275.  return "승인";
    276. 

  276. } 
    277. 

  277. else if ("{@judgrslt}" =="A"){
    278. 

  278.  return "시정승인";
    279. 

  279. }
    280. 

  280. else if ("{@judgrslt}" =="R"){
    281. 

  281.  return "반려";
    282. 

  282. }
    283. 

  283. else if ("{@judgrslt}" =="V"){
    284. 

  284.  return "보완후재심";
    285. 

  285. }
    286. 

  286. else if ("{@judgrslt}" =="S"){
    287. 

  287.  return "저장";
    288. 

  288. } 
    289. 

  289. else if ("{@judgrslt}" =="B"){
    290. 

  290.  return "부결";
    291. 

  291. }
    292. 

  292. else if ("{@judgrslt}" =="N"){
    293. 

  293.  return "승인된시험중지";
    294. 

  294. }
    295. 

  295. ]]></Field><Field Name="stdynm" ScriptType="1"><![CDATA[if ("{@stdykind4}" =="F"){
    296. 

  296.  return "1상";
    297. 

  297. } 
    298. 

  298. else if ("{@stdykind4}" =="S"){
    299. 

  299.  return "2상";
    300. 

  300. }
    301. 

  301. else if ("{@stdykind4}" =="T"){
    302. 

  302.  return "3상";
    303. 

  303. }
    304. 

  304. 

  305. else if ("{@stdykind4}" =="Y"){
    306. 

  306.  return "4상";
    307. 

  307. }
    308. 

  308. 

  309. else if ("{@stdykind4}" =="I"){
    310. 

  310.  return "학술연구";
    311. 

  311. }
    312. 

  312. 

  313. else if ("{@stdykind4}" =="P"){
    314. 

  314.  return "PK연구";
    315. 

  315. }
    316. 

  316. 

  317. else if ("{@stdykind4}" =="E"){
    318. 

  318.  return "기타";
    319. 

  319. }
    320. 

  320. ]]></Field><Field Name="reptnm" ScriptType="1"><![CDATA[if ("{@reptkind}" =="1"){
    321. 

  321.  return "보완답변서";
    322. 

  322. } 
    323. 

  323. else if ("{@reptkind}" =="2"){
    324. 

  324.  return "중간보고서";
    325. 

  325. }
    326. 

  326. else if ("{@reptkind}" =="3"){
    327. 

  327.  return "SAE(원내)";
    328. 

  328. }
    329. 

  329. 

  330. else if ("{@reptkind}" =="4"){
    331. 

  331.  return "SAE(원외)";
    332. 

  332. }
    333. 

  333. 

  334. else if ("{@reptkind}" =="5"){
    335. 

  335.  return "변경계획서";
    336. 

  336. }
    337. 

  337. 

  338. else if ("{@reptkind}" =="6"){
    339. 

  339.  return "종료보고서";
    340. 

  340. }
    341. 

  341. 

  342. else if ("{@reptkind}" =="7"){
    343. 

  343.  return "결과보고서";
    344. 

  344. }
    345. 

  345. else if ("{@reptkind}" =="8"){
    346. 

  346.  return "지속심의";
    347. 

  347. }
    348. 

  348. else if ("{@reptkind}" =="9"){
    349. 

  349.  return "계획서";
    350. 

  350. }
    351. 

  351. 

  352. ]]></Field><Field Name="stdykind1" ScriptType="1"><![CDATA[if ( "{@stdykind1}" == "M"){
    353. 

  353.  return "의약품";
    354. 

  354. } 
    355. 

  355. else if ( "{@stdykind1}" == "D"){
    356. 

  356.  return "의료기기";
    357. 

  357. } 
    358. 

  358. else if ( "{@stdykind1}" == "B"){
    359. 

  359.  return "생물학적제제";
    360. 

  360. } 
    361. 

  361. else if ( "{@stdykind1}" == "C"){
    362. 

  362.  return "세포치료제";
    363. 

  363. } 
    364. 

  364. else if ( "{@stdykind1}" == "H"){
    365. 

  365.  return "건강식품";
    366. 

  366. } 
    367. 

  367. else if ( "{@stdykind1}" == "R"){
    368. 

  368.  return "의무기록이용연구";
    369. 

  369. } 
    370. 

  370. else if ( "{@stdykind1}" == "O"){
    371. 

  371.  return "관찰연구";
    372. 

  372. } 
    373. 

  373. else if ( "{@stdykind1}" == "S"){
    374. 

  374.  return "보관검체이용연구";
    375. 

  375. } 
    376. 

  376. else if ( "{@stdykind1}" == "T"){
    377. 

  377.  return "시료연구 (조직 및 혈액)";
    378. 

  378. } 
    379. 

  379. else if ( "{@stdykind1}" == "P"){
    380. 

  380.  return "생동성연구";
    381. 

  381. } 
    382. 

  382. else if ( "{@stdykind1}" == "E"){
    383. 

  383.  return "기타";
    384. 

  384. } ]]></Field><Field Name="judgappdg" ScriptType="1"><![CDATA[return "( " + "{@judgappdg}" + " 차)"]]></Field><Field Name="judgdd" ScriptType="1"><![CDATA[return "{@judgdd}".substr(0, 4) + "-" + "{@judgdd}".substr(4, 2) + "-" + "{@judgdd}".substr(6, 2) + "      ( " + "{@judgappdg}" + " 차)"]]></Field></FieldSet><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="2" DataPath="D:\CMCOracle\application\webapps\crc\irbsubweb\rex\PRIIA00116.xml" DataRoot="root/main/rexjudgconf/item/datainfo" XslPath="" XsdPath="" CsvPath="" CsvRowSeparator="" CsvColumnSeparator=""><OrderInfos><OrderInfo ID="0" Method="0" GrpSectionIndex="2" OrderingFieldID="1" OrderingFieldIndex="7"><SpecifiedOrderInfo OtherTypesType="1" OtherTypesText=""/></OrderInfo></OrderInfos><FilterInfos/><SPInfo FunctionName=""/><SQL></SQL><ServerConnection URL="" DataType=""/></DataSetting><GlobalStyleManager><GlobalStyle Name="stdykind1M"><PropertySetting Name="Text" Value="의약품"/></GlobalStyle><GlobalStyle Name="stdykind1D"><PropertySetting Name="Text" Value="의료기기"/></GlobalStyle><GlobalStyle Name="stdykind1B"><PropertySetting Name="Text" Value="생물학적제제"/></GlobalStyle><GlobalStyle Name="stdykind1C"><PropertySetting Name="Text" Value="세포치료제"/></GlobalStyle><GlobalStyle Name="stdykind1H"><PropertySetting Name="Text" Value="건강식품"/></GlobalStyle><GlobalStyle Name="stdykind1R"><PropertySetting Name="Text" Value="의무기록 이용연구"/></GlobalStyle><GlobalStyle Name="stdykind1O"><PropertySetting Name="Text" Value="관찰연구"/></GlobalStyle><GlobalStyle Name="stdykind1S"><PropertySetting Name="Text" Value="보관검체 이용연구"/></GlobalStyle><GlobalStyle Name="stdykind1T"><PropertySetting Name="Text" Value="시료연구(조직 및 혈액 등)"/></GlobalStyle><GlobalStyle Name="stdykind1P"><PropertySetting Name="Text" Value="생동성연구"/></GlobalStyle><GlobalStyle Name="stdykind1E"><PropertySetting Name="Text" Value="기타"/></GlobalStyle><GlobalStyle Name="stdykindEtc"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="stdykind4Etc"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="stdykind1EtcN"><PropertySetting Name="Visible" Value="3"/></GlobalStyle><GlobalStyle Name="stdykind4EtcN"><PropertySetting Name="Visible" Value="3"/></GlobalStyle><GlobalStyle Name="stdykind4F"><PropertySetting Name="Text" Value="1상"/></GlobalStyle><GlobalStyle Name="stdykind4S"><PropertySetting Name="Text" Value="2상"/></GlobalStyle><GlobalStyle Name="stdykind4T"><PropertySetting Name="Text" Value="3상"/></GlobalStyle><GlobalStyle Name="stdykind4V"><PropertySetting Name="Text" Value="4상"/></GlobalStyle><GlobalStyle Name="stdykind4I"><PropertySetting Name="Text" Value="학술연구"/></GlobalStyle><GlobalStyle Name="stdykind4P"><PropertySetting Name="Text" Value="PK연구"/></GlobalStyle><GlobalStyle Name="stdykind4E"><PropertySetting Name="Text" Value="기타"/></GlobalStyle><GlobalStyle Name="irbjudgflagY"><PropertySetting Name="Text" Value="승인"/></GlobalStyle><GlobalStyle Name="irbjudgflagA"><PropertySetting Name="Text" Value="시정승인"/></GlobalStyle><GlobalStyle Name="irbjudgflagR"><PropertySetting Name="Text" Value="반려"/></GlobalStyle><GlobalStyle Name="irbjudgflagV"><PropertySetting Name="Text" Value="보완 후 재심"/></GlobalStyle><GlobalStyle Name="irbjudgflagS"><PropertySetting Name="Text" Value="저장"/></GlobalStyle><GlobalStyle Name="irbjudgflagB"><PropertySetting Name="Text" Value="부결"/></GlobalStyle><GlobalStyle Name="irbjudgflagN"><PropertySetting Name="Text" Value="승인된 시험 중지"/></GlobalStyle><GlobalStyle Name="visible"><PropertySetting Name="Visible" Value="0"/></GlobalStyle><GlobalStyle Name="hidden"><PropertySetting Name="Visible" Value="3"/></GlobalStyle></GlobalStyleManager><Page Gutter="0" MirrorMargin="0" Orientation="1" PaperSize="2" PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="100" LeftMargin="50" BottomMargin="100" RightMargin="50"><Section Type="128" Name="배경" Height="2770" 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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="0" Width="1900" Height="450" FitSection="0" LinkIndex="35" RoundLeftTopEdge="0" RoundRightTopEdge="0" RoundRightBottomEdge="0" RoundLeftBottomEdge="0" ExportLeft="0" ExportTop="0" ExportRight="0" ExportBottom="0"><CellStyles><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="0" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/><CellStyle LeftLineStyle="0" RightLineStyle="0" TopLineStyle="1" BottomLineStyle="0" FDiagonalLineStyle="0" BDiagonalLineStyle="0" LeftLineWidth="0" RightLineWidth="0" TopLineWidth="0.75" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="330"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="* 귀하가 신청하신 심의안건에 대하여 본임상연구심의위원회의 심의결과를 위와 같이 알려드립니다
    393. 

  393. * 만약 본위원회의 심사판정에 불복할 경우 심사결과 통보 후 2주일 이내 그 사유를 기록하여 본 위원회로 제출하여 
    394. 

  394.    주십시오.
    395. 

  395. * 본 임상연구심의위원회는 KGCP 및 ICH-GCP 규정을 준수하며, 생명윤리 및 안전에관한 법률 등 관련 법규를 준수
    396. 

  396.    합니다.
    397. 

  397. * 임상시험 문서보관 기한은 10년이며 그 이상 보관을 요청할 경우에는 비용 등 관련절차를 담당자와 상의하시기 바
    398. 

  398.    랍니다." MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="2" Editable="0" AutoFontSize="0" RowSpan="1" ColSpan="1" OutputFormat="" ReplaceEmpty="" SuppressIfDuplication="0" SuppressIfZero="0" SuppressText="" MergeIfSuppress="0" MergeColumn="0" AddEnterWhenMergeColumn="0" SummaryFunction="0" TopMargin="30" 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="1"><FieldReferences/><SummaryCondition/><HyperLinkInfo LinkType="0" LinkText="" ToolTipType="0" ToolTipText="" LinkFieldID="-1" LinkFieldIndex="-1" ToolTipFieldID="-1" ToolTipFieldIndex="-1"/><ConditionalStyles/><FieldReferences/></Cell></Row><Row Size="120"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" CanGrow="0" CanShrink="0" DataType="0" Text="가톨릭중앙의료원 중앙임상연구심의위원회  (직인)" 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="0" BottomMargin="0" RightMargin="0" FontName="굴림체" FontSize="16" 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></Row></Rows><Cols><Col Size="1900"/></Cols><ConditionalStyles/></Control></ListControls><ConditionalStyles/><Script><![CDATA[]]></Script></Section><Section Type="512" Name="서브리포트섹션3" Height="50" 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="1" PageReset2="1"><FieldLinks><FieldLink MainFieldID="1" MainFieldIndex="0" SubFieldID="1" SubFieldIndex="0"/><FieldLink MainFieldID="1" MainFieldIndex="7" SubFieldID="1" SubFieldIndex="7"/><FieldLink MainFieldID="1" MainFieldIndex="29" SubFieldID="1" SubFieldIndex="29"/></FieldLinks><ConditionalStyles/><Report Title="" Author="" Company="" Category="" Description="" CreatedDate="2008-04-04 16:29:34" LastSavedDate="2008-10-30 14:14:19" Version="2.5.1.78"><FieldInfo><FieldSet ID="1"><Field Name="judgappdg" Type="8" Size="0" Xpath="../judgappdg"/><Field Name="judgdd" Type="8" Size="0" Xpath="../judgdd"/><Field Name="judgweek" Type="8" Size="0" Xpath="../judgweek"/><Field Name="conftm" Type="8" Size="0" Xpath="../conftm"/><Field Name="confplc" Type="8" Size="0" Xpath="../confplc"/><Field Name="judgrslt" Type="8" Size="0" Xpath="../judgrslt"/><Field Name="judgitem1" Type="8" Size="0" Xpath="../judgitem1"/><Field Name="subjno" Type="8" Size="0" Xpath="../subjno"/><Field Name="itemnm" Type="8" Size="0" Xpath="../itemnm"/><Field Name="comnm" Type="8" Size="0" Xpath="../comnm"/><Field Name="respstdynm" Type="8" Size="0" Xpath="../respstdynm"/><Field Name="subjnm" Type="8" Size="0" Xpath="../subjnm"/><Field Name="stdykind4" Type="8" Size="0" Xpath="../stdykind4"/><Field Name="verplan" Type="8" Size="0" Xpath="../verplan"/><Field Name="veraprv" Type="8" Size="0" Xpath="../veraprv"/><Field Name="vercrf" Type="8" Size="0" Xpath="../vercrf"/><Field Name="verib" Type="8" Size="0" Xpath="../verib"/><Field Name="allentry" Type="8" Size="0" Xpath="../allentry"/><Field Name="etctrgt4" Type="8" Size="0" Xpath="../etctrgt4"/><Field Name="hospcd" Type="8" Size="0" Xpath="../hospcd"/><Field Name="hospnm" Type="8" Size="0" Xpath="../hospnm"/><Field Name="zipcd1" Type="8" Size="0" Xpath="../zipcd1"/><Field Name="zipcd2" Type="8" Size="0" Xpath="../zipcd2"/><Field Name="addr" Type="8" Size="0" Xpath="../addr"/><Field Name="telno" Type="8" Size="0" Xpath="../telno"/><Field Name="faxno" Type="8" Size="0" Xpath="../faxno"/><Field Name="cmpynm" Type="8" Size="0" Xpath="../cmpynm"/><Field Name="nm" Type="8" Size="0" Xpath="../nm"/><Field Name="stdykind1" Type="8" Size="0" Xpath="../stdykind1"/><Field Name="reptkind" Type="8" Size="0" Xpath="../reptkind"/><Field Name="irbzipcd1" Type="8" Size="0" Xpath="../irbzipcd1"/><Field Name="irbzipcd2" Type="8" Size="0" Xpath="../irbzipcd2"/><Field Name="irbaddr" Type="8" Size="0" Xpath="../irbaddr"/><Field Name="irbmngertelno" Type="8" Size="0" Xpath="../irbmngertelno"/><Field Name="irbmngernm" Type="8" Size="0" Xpath="../irbmngernm"/><Field Name="irbmngerfaxno" Type="8" Size="0" Xpath="../irbmngerfaxno"/><Field Name="deptnm" Type="8" Size="0" Xpath="../deptnm"/><Field Name="data" Type="8" Size="0" Xpath="data"/><Field Name="iisdversion" Type="8" Size="0" Xpath="../iisdversion"/><Field Name="head1" Type="8" Size="0" Xpath="../head1"/><Field Name="docno" Type="8" Size="0" Xpath="../docno"/><Field Name="judgnms" Type="8" Size="0" Xpath="../judgnms"/></FieldSet><FieldSet ID="2"/><FieldSet ID="3"><Field Name="judgnm" ScriptType="1"><![CDATA[if ("{@judgrslt}" =="Y"){
    399. 

  399.  return "승인";
    400. 

  400. } 
    401. 

  401. else if ("{@judgrslt}" =="A"){
    402. 

  402.  return "시정승인";
    403. 

  403. }
    404. 

  404. else if ("{@judgrslt}" =="R"){
    405. 

  405.  return "반려";
    406. 

  406. }
    407. 

  407. else if ("{@judgrslt}" =="V"){
    408. 

  408.  return "보완후재심";
    409. 

  409. }
    410. 

  410. else if ("{@judgrslt}" =="S"){
    411. 

  411.  return "저장";
    412. 

  412. } 
    413. 

  413. else if ("{@judgrslt}" =="B"){
    414. 

  414.  return "부결";
    415. 

  415. }
    416. 

  416. else if ("{@judgrslt}" =="N"){
    417. 

  417.  return "승인된시험중지";
    418. 

  418. }
    419. 

  419. ]]></Field><Field Name="stdynm" ScriptType="1"><![CDATA[if ("{@stdykind4}" =="F"){
    420. 

  420.  return "1상";
    421. 

  421. } 
    422. 

  422. else if ("{@stdykind4}" =="S"){
    423. 

  423.  return "2상";
    424. 

  424. }
    425. 

  425. else if ("{@stdykind4}" =="T"){
    426. 

  426.  return "3상";
    427. 

  427. }
    428. 

  428. 

  429. else if ("{@stdykind4}" =="Y"){
    430. 

  430.  return "4상";
    431. 

  431. }
    432. 

  432. 

  433. else if ("{@stdykind4}" =="I"){
    434. 

  434.  return "학술연구";
    435. 

  435. }
    436. 

  436. 

  437. else if ("{@stdykind4}" =="P"){
    438. 

  438.  return "PK연구";
    439. 

  439. }
    440. 

  440. 

  441. else if ("{@stdykind4}" =="E"){
    442. 

  442.  return "기타";
    443. 

  443. }
    444. 

  444. ]]></Field><Field Name="reptnm" ScriptType="1"><![CDATA[if ("{@reptkind}" =="1"){
    445. 

  445.  return "보완답변서";
    446. 

  446. } 
    447. 

  447. else if ("{@reptkind}" =="2"){
    448. 

  448.  return "중간보고서";
    449. 

  449. }
    450. 

  450. else if ("{@reptkind}" =="3"){
    451. 

  451.  return "SAE(원내)";
    452. 

  452. }
    453. 

  453. 

  454. else if ("{@reptkind}" =="4"){
    455. 

  455.  return "SAE(원외)";
    456. 

  456. }
    457. 

  457. 

  458. else if ("{@reptkind}" =="5"){
    459. 

  459.  return "변경계획서";
    460. 

  460. }
    461. 

  461. 

  462. else if ("{@reptkind}" =="6"){
    463. 

  463.  return "종료보고서";
    464. 

  464. }
    465. 

  465. 

  466. else if ("{@reptkind}" =="7"){
    467. 

  467.  return "결과보고서";
    468. 

  468. }
    469. 

  469. else if ("{@reptkind}" =="8"){
    470. 

  470.  return "지속심의";
    471. 

  471. }
    472. 

  472. else if ("{@reptkind}" =="9"){
    473. 

  473.  return "계획서";
    474. 

  474. }
    475. 

  475. 

  476. ]]></Field><Field Name="stdykind1" ScriptType="1"><![CDATA[if ( "{@stdykind1}" == "M"){
    477. 

  477.  return "의약품";
    478. 

  478. } 
    479. 

  479. else if ( "{@stdykind1}" == "D"){
    480. 

  480.  return "의료기기";
    481. 

  481. } 
    482. 

  482. else if ( "{@stdykind1}" == "B"){
    483. 

  483.  return "생물학적제제";
    484. 

  484. } 
    485. 

  485. else if ( "{@stdykind1}" == "C"){
    486. 

  486.  return "세포치료제";
    487. 

  487. } 
    488. 

  488. else if ( "{@stdykind1}" == "H"){
    489. 

  489.  return "건강식품";
    490. 

  490. } 
    491. 

  491. else if ( "{@stdykind1}" == "R"){
    492. 

  492.  return "의무기록이용연구";
    493. 

  493. } 
    494. 

  494. else if ( "{@stdykind1}" == "O"){
    495. 

  495.  return "관찰연구";
    496. 

  496. } 
    497. 

  497. else if ( "{@stdykind1}" == "S"){
    498. 

  498.  return "보관검체이용연구";
    499. 

  499. } 
    500. 

  500. else if ( "{@stdykind1}" == "T"){
    501. 

  501.  return "시료연구 (조직 및 혈액)";
    502. 

  502. } 
    503. 

  503. else if ( "{@stdykind1}" == "P"){
    504. 

  504.  return "생동성연구";
    505. 

  505. } 
    506. 

  506. else if ( "{@stdykind1}" == "E"){
    507. 

  507.  return "기타";
    508. 

  508. } ]]></Field><Field Name="judgappdg" ScriptType="1"><![CDATA[return "( " + "{@judgappdg}" + " 차)"]]></Field><Field Name="judgdd" ScriptType="1"><![CDATA[return "{@judgdd}".substr(0, 4) + "-" + "{@judgdd}".substr(4, 2) + "-" + "{@judgdd}".substr(6, 2) + "      ( " + "{@judgappdg}" + " 차)"]]></Field></FieldSet><FieldSet ID="4"/></FieldInfo><DataSetting EncryptSQL="1" ConnectionString="" DynamicSQL="0" SQLScriptType="1" RecordType="2" DataPath="D:\CMCOracle\application\webapps\crc\irbsubweb\rex\PRIIA00116.xml" DataRoot="root/main/rexjudgconf/item/datainfo" XslPath="" XsdPath="" CsvPath="" CsvRowSeparator="" CsvColumnSeparator=""><OrderInfos><OrderInfo ID="0" Method="0" GrpSectionIndex="2" OrderingFieldID="1" OrderingFieldIndex="7"><SpecifiedOrderInfo OtherTypesType="1" OtherTypesText=""/></OrderInfo></OrderInfos><FilterInfos/><SPInfo FunctionName=""/><SQL></SQL><ServerConnection URL="" DataType=""/></DataSetting><GlobalStyleManager><GlobalStyle Name="stdykind1M"><PropertySetting 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RightLineWidth="0" TopLineWidth="0.75" BottomLineWidth="0" FDiagonalLineWidth="0.75" BDiagonalLineWidth="0.75" LeftLineColor="0" RightLineColor="0" TopLineColor="0" BottomLineColor="0" FDiagonalLineColor="0" BDiagonalLineColor="0"/></CellStyles><Rows><Row Size="330"><Cell CellType="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="0" VerticalAlignment="0" CanGrow="0" CanShrink="0" DataType="0" Text="* 귀하가 신청하신 심의안건에 대하여 본임상연구심의위원회의 심의결과를 위와 같이 알려드립니다
    517. 

  517. * 만약 본위원회의 심사판정에 불복할 경우 심사결과 통보 후 2주일 이내 그 사유를 기록하여 본 위원회로 제출하여 
    518. 

  518.    주십시오.
    519. 

  519. * 본 임상연구심의위원회는 KGCP 및 ICH-GCP 규정을 준수하며, 생명윤리 및 안전에관한 법률 등 관련 법규를 준수
    520. 

  520.    합니다.
    521. 

  521. * 임상시험 문서보관 기한은 10년이며 그 이상 보관을 요청할 경우에는 비용 등 관련절차를 담당자와 상의하시기 바
    522. 

  522.    랍니다." 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PaperWidth="2100" PaperHeight="2970" ReportWidth="2100" TopMargin="100" LeftMargin="50" BottomMargin="100" RightMargin="50"><Section Type="1" Name="보고서머리글" Height="50" 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" 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="1750" 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="글상자2" Visible="0" X1="75" Y1="0" Width="1850" Height="100" LineStyle="0" LineWidth="0.75" LineColor="0" RoundRate="0" SquareRound="0" BackStyle="0" BackColor="16777215" FillStyle="0" FillColor="0" Alignment="1" VerticalAlignment="1" Text="연구자의 임상시험/연구 수행시 지켜야 할 사항" MultiLine="1" WordWrap="1" WordSpace="0" LineSpace="0" Editable="0" AutoFontSize="0" TopMargin="0" LeftMargin="0" BottomMargin="0" RightMargin="0" FontName="바탕체" FontSize="16" 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="글상자3" Visible="0" X1="75" Y1="150" Width="1850" Height="1600" 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.  위원회의 승인을 받은 계획서에 따라 연구를 수행하십시오.
    523. 

  523. 2.  위원회의 승인을 받은 피험자 동의서를 사용하십시오.
    524. 

  524. 3.  모국어가 한국어가 아닌 피험자들에게는 승인된 동의서를 피험자의 모국어로 인증된 번역본을 
    525. 

  525.     사용할 것이며, 이러한 동의서 번역본은 반드시 위원회 승인을 받아야 합니다.
    526. 

  526. 4.  연구진행에 있어 피험자를 보호하기 위해 불가피한 경우를 제외하고 연구의 어떠한 변경이든 
    527. 

  527.     위원회의 사전 승인을 받고 수행하십시오. 피험자들의 보호를 위해 취해진 어떠한 응급상황에
    528. 

  528.     서의 변경도 즉각 위원회에 보고 해야합니다.
    529. 

  529. 5.  위원회에서 승인된 계획서에 따라 등록된 어떠한 피험자라도 사망, 입원, 심각한 부작용에 대
    530. 

  530.     하여는 위원회에 서면으로 보고해야 합니다.
    531. 

  531. 6.  임상시험 또는 피험자의 안전에 대해 유해한 영향을 미칠 수 있는 어떠한 새로운 정보도 즉각
    532. 

  532.     적으로 위원회에 보고해야 합니다.
    533. 

  533. 7.  위원회의 요구가 있을 때에는 연구의 진행과 관련된 보고를 위원회에 제출해 주시기 바랍니다.
    534. 

  534. 8.  피험자 모집광고는 사용 전에 위원회로부터 승인을 득한후 사용해야 합니다.
    535. 

  535. 9.  강제 혹은 부당한 영향이 없는 상태에서 충분한 설명에 근거한 동의 과정을 수행할 것이며, 잠
    536. 

  536.     재적인 피험자에게 연구에의 참여여부를 고려할 수 있도록 충분히 기회를 제공해야 합니다.  
    537. 

  537. 10. 위원회의 승인 후 연구를 개시하게 되면 적어도 연 1회 이상 중간보고서 를 지속심의신청서와 
    538. 

  538.     함께 제출하여야 합니다.
    539. 

  539. 11. 임상시험이 종료(조기종료를 포함한다)된 경우, 연구종료 요약자료와 함께 임상시험 종료 사실
    540. 

  540.     을 서식 21-02에 따라 위원회에 보고하여야 합니다. 
    541. 

  541. 12. 결과보고에 대한 내용 첨가는 연구 종료 1년 이내에 서식21-03을 작성하여 위원회에 제출해야 
    542. 

  542.     하고, 또한 연구 결과의 학술 논문 형식의 발표는 위원회의 승인 이후에만 가능하며, 논문에 본 
    543. 

  543.     위원회로부터 계획서에 대한 심의와 승인을 받았다는 사실을 명시해야 합니다. 결과보고서를 연
    544. 

  544.     구 종료 1년 이내에 제출하지 않은 연구책임자의 경우 이후 연구책임자로서 본 위원회에 계획서
    545. 

  545.     를 제출하는 것을 제한할 수 있습니다.
    546. 

  546. 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    547.