SAE(원외)

연구자 인과관계 평가 최초임상시험 계획서 심사일자 선택된병원 남 M 여 F 접수여부 피험자 정보 이상 약물 반응 보고분류 Report No/ Patient No 접수 Y 미접수 N 이상반응내용 심사차수

<input id="ipt_fstplanjudgdd" ref="/root/main/reptdetl/item/fstplanjudgdd" class="input_search" disabled="true" inputtype="date" style="left:392px; top:32px; width:100px; height:19px; "/>
		<select1 id="cmb_trobreactcls" ref="/root/main/reptdetl/item/trobreactcls" class="combo_search" disabled="true" appearance="minimal" style="left:166px; top:252px; width:449px; height:19px; ">
			<choices>
				<item>
					<label>사망</label>
					<value>1</value>
				</item>
				<item>
					<label>생명을 위협하는 경우</label>
					<value>2</value>
				</item>
				<item>
					<label>입원 또는 입원 기간의 연장이 필요한 경우</label>
					<value>3</value>
				</item>
				<item>
					<label>지속적 또는 의미있는 불구나 기능저하를 초래하는 경우</label>
					<value>4</value>
				</item>
				<item>
					<label>선천적 기형 또는 이상을 초래하는 경우</label>
					<value>5</value>
				</item>
				<item>
					<label>기타 의학적으로 중요한 경우</label>
					<value>6</value>
				</item>
			</choices>
		</select1>
		<button id="btn_filedel" class="btn5_letter4" _auth="X" style="left:818px; top:5px; width:64px; height:19px; ">
			<caption>첨부삭제</caption>
			<script type="javascript" ev:event="onclick">
				<![CDATA[
					//접수 후 수정불가
					if ( model.getValue("/root/main/reptdetl/item/acptyn") == "Y" ) {
						messageBox("이미 접수되어 저장 또는 수정", "E001");
						return;
					} else {
						
						if (submit("TXIRS00198")) {
							messageBox("첨부파일이 삭제되었습니다.","I999");
							
							model.refresh();
						}
					}
					if ( model.getValue("/root/hidden/ret/reptseqno") != '' ) {
						submit("TRIRB00104");   //SAE(원외) 내용 조회
					}
				]]>
			</script>
		</button>
		<input id="ipt_filenm" ref="/root/main/reptdetl/item/attfile" class="input_default" style="left:550px; top:5px; width:200px; height:19px; "/>
		<button id="btn_fileatt" class="btn2_letter4" _auth="X" style="left:752px; top:5px; width:64px; height:19px; ">
			<caption>파일첨부</caption>
			<script type="javascript" ev:event="onclick">
				<![CDATA[
					if ( model.getValue("/root/main/reptdetl/item/acptyn") == '' ) {
						messageBox("임시저장 후 첨부파일을 올리세요", "I");
						return;
					}
				
					var maxsize  = upload1.attribute("filesize");
					
					files = window.fileDialog("open", "|", true);
					filelist = files.split("|");
					for(var i = 0 ; i < filelist.length ; i++ )	{
						grd_attach.addRow(false);
						grd_attach.valueMatrix(grd_attach.rows - 1, 0) = filelist[i];
						if (!checkFileSize(upload1)){
							grd_attach.removeItem();
							messageBox("파일 크기가 최대치("+maxsize+"Byte)를", "E003");							
							return;
						}
					}
					
					if ( filelist[0] != "") {
						
						if (submit("TXIRS00199")) {
							messageBox("Upload가 성공적으로 이루어졌습니다.","I999");
							model.removeNodeset("/root/send/attach");
							parent.model.setValue("/root/temp/ivieweryn", "N");   //중간보고서 iviewer 호출 여부 = N
							parent.btn_report4.selected = true;
							parent.btn_report4.dispatch("DOMActivate");
							model.refresh();						
						}
					}
					
					submit("TRIRB00104");   //SAE(원외) 내용 조회
					model.setValue("/root/main/reptdetl/item/subjid", parent.model.getValue("/root/send/searchitem2/subjid"));
					model.setValue("/root/main/reptdetl/item/instcd", parent.model.getValue("/root/send/searchitem2/instcd"));
					model.setValue("/root/main/reptdetl/item/judgappdg", parent.model.getValue("/root/send/searchitem2/judgappdg"));
					model.setValue("/root/main/reptdetl/item/roothospidxcasecnt", parent.model.getValue("/root/send/searchitem2/roothospidxcasecnt"));
					model.setValue("/root/main/reptdetl/item/subjno", parent.model.getValue("/root/send/searchitem2/subjno"));
					model.setValue("/root/main/reptdetl/item/subjnm", parent.model.getValue("/root/send/searchitem2/subjnm"));
					model.setValue("/root/main/reptdetl/item/fstplanjudgdd", parent.model.getValue("/root/send/searchitem2/judgdd"));
					model.setValue("/root/main/reptdetl/item/screenmenu", parent.model.getValue("/root/init/screenmenu"));
					model.setValue("/root/main/reptdetl/item/stdykind2", parent.model.getValue("/root/send/searchitem2/stdykind2"));
					model.setValue("/root/main/reptdetl/item/rc", parent.model.getValue("/root/send/searchitem2/rc"));
					model.refresh();				
				]]>
			</script>
		</button>
		<button id="btn_tmpsave" class="btn2_letter4" _auth="X" style="left:885px; top:5px; width:64px; height:19px; ">
			<caption>임시저장</caption>
			<script type="javascript" ev:event="DOMActivate">
				<![CDATA[
					//접수 후 수정불가
					if ( model.getValue("/root/main/reptdetl/item/acptyn") == "Y" ) {
						messageBox("이미 접수되어 저장 또는 수정", "E001");
						return;
					}
					// ***** 2009.10.23(김재우 추가) *****
					if (add_validationchk() == false){
						return;
					}
					// ***** 2009.10.23 *****
					var reptseqno = model.getValue("/root/hidden/ret/reptseqno");
					if ( reptseqno != '') {
						model.setValue("/root/main/reptdetl/item/reptseqno", model.getValue("/root/hidden/ret/reptseqno"));
					}
					
					model.copyNode("/root/send/savedata", "/root/main/reptdetl/item");
					model.setValue("/root/send/savedata/reptkind", "4");   //보고서종류=SAE(원외)(4)
					model.setValue("/root/send/savedata/acptyn", "N");   //접수여부=미접수(N)
					model.makeValue("/root/send/savedata/croinstcd", model.getValue("/root/send/searchitem/croinstcd")); 
					model.makeValue("/root/send/savedata/judgkind", "N");  //심의종류
					
					//피험자정보 그리드 필수입력항목 체크
			/*		var update = getGridUpdateData(grd_test);
					if ( update != "" ) {
						for ( i=1; i<grd_test.rows; i++ ) {
							if ( model.getValue("/root/main/reptdetl/test["+ i +"]/testeeid") == "" ) {
								messageBox("피험자번호를", "C001");
								return;
							}
						}
						model.makeNode("/root/send/savedata/test");
						model.setValue("/root/send/savedata/test", update);
					}
				*/	
					for ( i = 1; i < grd_test.rows; i++ ) {
						model.setValue("/root/main/reptdetl/test["+ i +"]/reptseqno", model.getValue("/root/send/searchitem/reptseqno"));					
					}
					
					var update1 =  instance1.selectNodes("/root/main/reptdetl/test");				
					var rCSV1 = getNodeListCSV(update1);
					
					if ( rCSV1 != null ) {
						for ( i = 1;  i < grd_test.rows; i++ ) {
							if ( model.getValue("/root/main/reptdetl/test["+ i +"]/testeeid") == "" ) {
								messageBox("피험자번호를", "C001");
								return;
							}						
						}
						model.makeNode("/root/send/savedata/test");						
						model.setValue("/root/send/savedata/test", rCSV1);
					}
					
					
					if (model.getValue("/root/send/searchitem/consorflag") == 'Y') {
						var instcd = model.getValue("/root/send/savedata/instcd");
						if ( instcd == '' ) {
							messageBox("병원을 ", "C002");
						}
						else {
							submit("TXIRB00102");
						}
					} else {
						submit("TXIRB00101");
					}
					
					grd_test.clearStatus();
					
					model.resetInstanceNode("/root/send/savedata");
					model.removenode("/root/send/savedata/test");
					
					model.setValue("/root/main/reptdetl/item/acptyn", "N");   //접수여부를 미접수로 보여줌.
					model.setValue( "/root/send/searchitem/reptseqno",model.getValue("/root/hidden/ret/reptseqno"));
					model.refresh();
					parent.model.setValue("/root/temp/ivieweryn", "N");   //SAE(원외) iviewer 호출 여부 = N
					parent.btn_report4.selected = true;
					parent.btn_report4.dispatch("DOMActivate");
					model.removeNodeset("/root/send/savedata");
					model.makeNode("/root/send/savedata");
				]]>
			</script>
		</button>
		<button id="btn_reptacpt" class="btn2_letter5" _auth="X" style="left:997px; top:5px; width:75px; height:19px; ">
			<caption>보고서접수</caption>
			<script type="javascript" ev:event="DOMActivate">
				<![CDATA[
					//접수 후 수정불가
					if ( model.getValue("/root/main/reptdetl/item/acptyn") == "Y" ) {
						messageBox("이미 접수되어 저장 또는 수정", "E001");
						return;
					}
					// ***** 2009.10.23(김재우 추가) *****
					if (add_validationchk() == false){
						return;
					}
					// ***** 2009.10.23 *****
					var reptseqno = model.getValue("/root/hidden/ret/reptseqno");
					if ( reptseqno != '') {
						model.setValue("/root/main/reptdetl/item/reptseqno", model.getValue("/root/hidden/ret/reptseqno"));
					}
					
					model.copyNode("/root/send/savedata", "/root/main/reptdetl/item");
					model.setValue("/root/send/savedata/reptkind", "4");   //보고서종류=SAE(원외)(4)
					model.setValue("/root/send/savedata/acptyn", "Y");   //접수여부=접수(Y)
					model.setValue("/root/send/savedata/acptdd", getCurrentDate());   //접수일=오늘날짜
					model.makeValue("/root/send/savedata/croinstcd", model.getValue("/root/send/searchitem/croinstcd")); 
					model.makeValue("/root/send/savedata/judgkind", "N");  //심의종류
					
				/*	//피험자정보 그리드 필수입력항목 체크
					var update = getGridUpdateData(grd_test);
					if ( update != "" ) {
						for ( i=1; i<grd_test.rows; i++ ) {
							if ( model.getValue("/root/main/reptdetl/test["+ i +"]/testeeid") == "" ) {
								messageBox("피험자번호를", "C001");
								return;
							}
						}
						model.makeNode("/root/send/savedata/test");
						model.setValue("/root/send/savedata/test", update);
					}
				*/
					
					for ( i = 1; i < grd_test.rows; i++ ) {
						model.setValue("/root/main/reptdetl/test["+ i +"]/reptseqno", model.getValue("/root/send/searchitem/reptseqno"));					
					}
					
					var update1 =  instance1.selectNodes("/root/main/reptdetl/test");				
					var rCSV1 = getNodeListCSV(update1);
					
					if ( rCSV1 != null ) {
						for ( i = 1;  i < grd_test.rows; i++ ) {
							if ( model.getValue("/root/main/reptdetl/test["+ i +"]/testeeid") == "" ) {
								messageBox("피험자번호를", "C001");
								return;
							}						
						}
						model.makeNode("/root/send/savedata/test");						
						model.setValue("/root/send/savedata/test", rCSV1);
					}
					
					if (model.getValue("/root/send/searchitem/consorflag") == 'Y') {
						var instcd = model.getValue("/root/send/savedata/instcd");
						if ( instcd == '' ) {
							messageBox("병원을 ", "C002");
						}
						else {
							submit("TXIRB00102");
						}
					} else {
						submit("TXIRB00101");
					}
					
					model.resetInstanceNode("/root/send/savedata");
					model.removenode("/root/send/savedata/test");
					
					model.setValue("/root/main/reptdetl/item/acptyn", "Y");   //접수여부를 접수로 보여줌.
					model.setValue( "/root/send/searchitem/reptseqno",model.getValue("/root/hidden/ret/reptseqno"));
					model.refresh();
					parent.model.setValue("/root/temp/ivieweryn", "N");   //SAE(원외) iviewer 호출 여부 = N
					parent.btn_report4.selected = true;
					parent.btn_report4.dispatch("DOMActivate");
					model.removeNodeset("/root/send/savedata");
					model.makeNode("/root/send/savedata");
				]]>
			</script>
		</button>
		<caption id="caption7" class="tit_2" style="left:10px; top:10px; width:140px; height:14px; ">SAE(원외)</caption>
		<button id="btn_filedown" class="btn2_letter4" visibility="hidden" _auth="R" style="left:755px; top:5px; width:64px; height:19px; ">
			<caption>내려받기</caption>
			<script type="javascript" ev:event="DOMActivate">
				<![CDATA[
				
					var s = model.getValue("/root/main/reptdetl/item/attfile");
					var ss = s.split("/");
					var filepath = "";
					var filenm = "";
					for ( var i = 0; i < ss.length; i ++){
						if ( i < ss.length -2  ) {
							filepath = filepath+ss[i] +"/";
						} else if ( i < ss.length -1  ) {
							filepath = filepath+ss[i] ;
						} else {
							filenm = ss[i];
						}
						
					}
					
					
					var localfile = window.fileDialog("save","|",false,filenm,"","All Files(*.*)|*.*");
					if (localfile != "") {		
						model.download(getActionURL("TRIRS00105")+"&filepath="+filepath,localfile);
						var rtn = messageBox("파일을", "Q004");
						if( rtn == 6  ) {
							window.exec(localfile);	
						}
					}
				]]>
			</script>
		</button>
		<upload id="upload1" nodeset="/root/send/attach/file" ext="zip" filecount="5" filesize="52428800" validate="true" style="left:695px; top:70px; width:100px; height:20px; "/>
		<datagrid id="grd_attach" nodeset="/root/send/attach" visibility="hidden" caption="파일경로^" colwidth="644" extendlastcol="scroll" mergecellsfixedrows="bycolrec" style="left:225px; top:50px; width:665px; height:150px; ">
			<col ref="file"/>
		</datagrid>
		<button id="button1" class="btn5_letter2" _auth="X" style="left:952px; top:5px; width:42px; height:19px; ">
			<caption>삭제</caption>
			<script type="javascript" ev:event="DOMActivate">
				<![CDATA[
					//접수 후 수정불가
					if ( model.getValue("/root/main/reptdetl/item/acptyn") == "Y" ) {
						messageBox("이미 접수되어 저장 또는 수정", "E001");
						return;
					}
					
					var reptseqno = model.getValue("/root/hidden/ret/reptseqno");
					if ( reptseqno != '') {
						model.setValue("/root/main/reptdetl/item/reptseqno", model.getValue("/root/hidden/ret/reptseqno"));
					}
				
					if (model.getValue("/root/send/searchitem/consorflag") == 'Y') {
						submit("TXIRB00104");						
					} else {
						submit("TXIRB00103");
					}
				
					model.refresh();
					parent.model.setValue("/root/temp/ivieweryn", "N");   //SAE(원외) iviewer 호출 여부 = N
					parent.btn_report4.selected = true;
					parent.btn_report4.dispatch("DOMActivate");
				]]>
			</script>
		</button>
		<select1 id="combo1" ref="/root/main/reptdetl/item/cnts3" class="combo_search" appearance="minimal" style="left:167px; top:303px; width:448px; height:19px; ">
			<choices>
				<item>
					<label>관련성이 명백함</label>
					<value>1</value>
				</item>
				<item>
					<label>관련성이 많음</label>
					<value>2</value>
				</item>
				<item>
					<label>관련성이 의심됨</label>
					<value>3</value>
				</item>
				<item>
					<label>관련성이 적음</label>
					<value>4</value>
				</item>
				<item>
					<label>관련성이 없음</label>
					<value>5</value>
				</item>
				<item>
					<label>평가 불가능</label>
					<value>6</value>
				</item>
			</choices>
		</select1>
		<caption id="caption1" style="left:645px; top:425px; width:450px; height:144px; font-size:10pt; font-weight:bold; color:#ff0000; vertical-align:top; line-spacing:9; ">
			<![CDATA[** 원외 이상반응 보고가 2건 이상인 경우에는 따로 작성하지 마시고, 
   '이상반응내용' 입력란에 이상반응 여러 건을 한 번에 입력하여 
   주시기 바랍니다. 각 건당 필수 입력 사항은 위와 동일합니다.
*** 위의 내용이 다 포함되지 않을 경우 보고서가 반려될 수도 있음을
   알려드립니다.
]]>
		</caption>
		<caption id="caption2" style="left:665px; top:130px; width:410px; height:288px; font-size:10pt; font-weight:bold; color:#0000ff; vertical-align:top; line-spacing:9; ">
			<![CDATA[1. Report No./Patient No.
2. 보고 분류(초회/추적) 
3. 이상반응 분류(심각도에 따른 6가지 분류 중 한 가지 선택)
4. 이상반응 내용
5. 연구자 인과 관계 평가(임상용 의약품과의 인과관계 여부)
6. 예상가능성 여부(expected or unexpected) - 예상 가능한 
   이상반응인 경우 근거 첨부
7. 스폰서 주도의 연구인 경우 스폰서의 의견
8. 계획서/동의서 변경이 필요한지 여부
  -> 임상용 의약품과 인과 관계가 있으면서 예상 불가능한 
      중대한 이상반응의 경우 본원 연구의 지속 여부에 대한 
      연구자의 의견을 첨부해 주시기 바랍니다.]]>
		</caption>
		<select id="checkbox1" ref="/root/main/reptdetl/item/reptclsyn1" overflow="visible" appearance="full" style="left:138px; top:183px; width:70px; height:19px; border-style:none; ">
			<choices>
				<item>
					<label>초회보고</label>
					<value>Y</value>
				</item>
			</choices>
		</select>
		<select id="chk_reptcls" ref="/root/main/reptdetl/item/reptclsyn2" overflow="visible" appearance="full" style="left:212px; top:183px; width:70px; height:19px; border-style:none; ">
			<choices>
				<item>
					<label>추적보고</label>
					<value>Y</value>
				</item>
			</choices>
		</select>
		<select id="checkbox2" ref="/root/main/reptdetl/item/reptclsyn3" overflow="visible" appearance="full" style="left:287px; top:183px; width:70px; height:19px; border-style:none; ">
			<choices>
				<item>
					<label>최종보고</label>
					<value>Y</value>
				</item>
			</choices>
		</select>
		<select id="checkbox3" ref="/root/main/reptdetl/item/trobreactreptyn1" overflow="visible" appearance="full" style="left:55px; top:232px; width:375px; height:19px; border-style:none; ">
			<choices>
				<item>
					<label>이상반응(계획서에 보고하지 않아도 된다고 명시된 사항은 제외)</label>
					<value>Y</value>
				</item>
			</choices>
		</select>
		<select id="checkbox4" ref="/root/main/reptdetl/item/trobreactreptyn2" class="cell_1" overflow="visible" appearance="full" style="left:55px; top:252px; width:110px; height:19px; border-style:none; ">
			<choices>
				<item>
					<label>중대한 이상반응</label>
					<value>Y</value>
				</item>
			</choices>
			<script type="javascript" ev:event="xforms-value-changed">
				<![CDATA[
					var trobreactyn = model.getValue("/root/main/reptdetl/item/trobreactreptyn2");
					if(trobreactyn == "Y") 
						cmb_trobreactcls.disabled = false;
					else
						cmb_trobreactcls.disabled = true;
				]]>
			</script>
		</select>
		<select1 id="combo2" ref="/root/main/reptdetl/item/cnts11" class="combo_search" appearance="minimal" style="left:167px; top:275px; width:63px; height:19px; ">
			<choices>
				<item>
					<label>예</label>
					<value>1</value>
				</item>
				<item>
					<label>아니오</label>
					<value>2</value>
				</item>
			</choices>
			<script type="javascript" ev:event="xforms-value-changed">
				<![CDATA[
					var cnts11 = model.getValue("/root/main/reptdetl/item/cnts11");
					if(cnts11 == "1") 
						input5.disabled = false;
					else
						input5.disabled = true;
				]]>
			</script>
		</select1>
		<caption id="caption13" class="cell_1" style="left:233px; top:273px; width:46px; height:23px; text-align:center; vertical-align:middle; ">근거</caption>
		<caption id="caption5" class="cell_1" style="left:55px; top:273px; width:110px; height:23px; text-align:center; vertical-align:middle; ">예상가능</caption>
		<input id="input5" ref="/root/main/reptdetl/item/cnts19" class="input_default" disabled="true" style="left:282px; top:275px; width:333px; height:19px; "/>
		<caption id="caption14" class="cell_1" style="left:5px; top:490px; width:100px; height:48px; text-align:center; vertical-align:middle; ">
			<![CDATA[피험자 보호를
 위한 조치]]>
		</caption>
		<caption id="caption15" class="cell_1" style="left:106px; top:490px; width:294px; height:23px; text-align:left; vertical-align:middle; ">연구 계획서의 변경이 필요한가?</caption>
		<caption id="caption16" class="cell_1" style="left:106px; top:515px; width:294px; height:23px; text-align:left; vertical-align:middle; ">피험자 설명문 및 동의서 변경이 필요한가?</caption>
		<select1 id="combo8" ref="/root/main/reptdetl/item/subtesteeproctyn1" class="combo_search" appearance="minimal" style="left:408px; top:492px; width:207px; height:19px; ">
			<choices>
				<item>
					<label>
						<![CDATA[예(-> 변경계획서 첨부)]]>
					</label>
					<value>Y</value>
				</item>
				<item>
					<label>아니오</label>
					<value>N</value>
				</item>
			</choices>
		</select1>
		<select1 id="combo9" ref="/root/main/reptdetl/item/subtesteeproctyn2" class="combo_search" appearance="minimal" style="left:408px; top:517px; width:207px; height:19px; ">
			<choices>
				<item>
					<label>
						<![CDATA[예(-> 변경계획서 첨부)]]>
					</label>
					<value>Y</value>
				</item>
				<item>
					<label>아니오</label>
					<value>N</value>
				</item>
			</choices>
		</select1>
		<caption id="caption3" style="left:645px; top:80px; width:430px; height:72px; font-size:10pt; font-weight:bold; color:#ff0000; vertical-align:top; line-spacing:9; ">
			<![CDATA[* 원외 이상반응 보고 시 다음과 같은 사항이 모두 기재되어 있는지
  반드시 확인 후 제출하시기 바랍니다.
]]>
		</caption>
		<line id="line1" class="line_3" style="x1:5px; y1:540px; x2:615px; y2:540px; "/>
	</xhtml:body>
</xhtml:html>