<![CDATA[
<p> </p><p> </p><div class="figure-file" data-ke-type="file" data-file-src="https://t1.daumcdn.net/cafeattach/1Yuf4/cf1f071378dda36f159128210d345f7bb511a9c7?download" data-file-name="[1.28.금.조간]_「신의료기술평가에_관한_규칙」일부개정안_공포(1.28.).hwp" data-file-size="440832" data-mimetype="application/haansofthwp" data-ke-align="alignCenter"><a href='javascript:fileFilterViewer("https://t1.daumcdn.net/cafeattach/1Yuf4/cf1f071378dda36f159128210d345f7bb511a9c7?download", "/cafeattach/1Yuf4/cf1f071378dda36f159128210d345f7bb511a9c7", "[1.28.금.조간]_「신의료기술평가에_관한_규칙」일부개정안_공포(1.28.).hwp", "grpid%3D1Yuf4%26fldid%3DDRP7%26dataid%3D692%26fileid%3D1%26regdt%3D20220127185128&url=https%3A%2F%2Ft1.daumcdn.net%2Fcafeattach%2F1Yuf4%2Fcf1f071378dda36f159128210d345f7bb511a9c7")'><div class="image"></div><div class="desc"><div class="filename"><span class="name">[1.28.금.조간]_「신의료기술평가에_관한_규칙」일부개정안_공포(1.28.)</span><span class="type">.hwp</span></div><div class="size">430.50KB</div></div></a></div><p> </p><p> </p><p> </p><div class="table-wrap"><table data-ke-type="table" data-ke-align="alignLeft" style="width: 100%;" border="1"><tbody><tr><td><span style="color: #000000;">평가</span><span style="color: #000000;"> </span><span style="color: #000000;">유예</span><span style="color: #000000;"> </span><span style="color: #000000;">신의료기술</span><span style="color: #000000;"> </span><span style="color: #000000;">사용</span><span style="color: #000000;"> </span><span style="color: #000000;">중</span><span style="color: #000000;"> </span><span style="color: #000000;">이상</span><span style="color: #000000;"> </span><span style="color: #000000;">반응</span><span style="color: #000000;"> </span><span style="color: #000000;">보고</span><span style="color: #000000;"> </span><span style="color: #000000;">절차가</span><span style="color: #000000;"> </span><span style="color: #000000;">있나요</span><span style="color: #000000;">?</span><span style="color: #000000;"> </span><span style="color: #000000;">이상반응</span><span style="color: #000000;"> </span><span style="color: #000000;">보고는</span><span style="color: #000000;"> </span><span style="color: #000000;">누가</span><span style="color: #000000;"> </span><span style="color: #000000;">하나요</span><span style="color: #000000;">?</span></td></tr></tbody></table></div><p><span style="color: #000000;"> </span></p><p><span style="color: #000000;">○</span><span style="color: #000000;"> </span><span style="color: #000000;">중대한</span><span style="color: #000000;"> </span><span style="color: #000000;">이상</span><span style="color: #000000;"> </span><span style="color: #000000;">반응․이상</span><span style="color: #000000;"> </span><span style="color: #000000;">신체</span><span style="color: #000000;"> </span><span style="color: #000000;">반응이</span><span style="color: #000000;"> </span><span style="color: #000000;">발생하는</span><span style="color: #000000;"> </span><span style="color: #000000;">경우</span><span style="color: #000000;">, </span><span style="color: #000000;">인지한</span><span style="color: #000000;"> </span><span style="color: #000000;">시점으로</span><span style="color: #000000;">부터</span><span style="color: #000000;"> </span><span style="color: #000000;">아래와</span><span style="color: #000000;"> </span><span style="color: #000000;">같이</span><span style="color: #000000;"> </span><span style="color: #000000;">일정</span><span style="color: #000000;"> </span><span style="color: #000000;">시간</span><span style="color: #000000;"> </span><span style="color: #000000;">이내</span><span style="color: #000000;"> </span><span style="color: #000000;">보고서를</span><span style="color: #000000;"> </span><span style="color: #000000;">작성하여</span><span style="color: #000000;"> </span><a href="mailto:safety@neca.re.kr" target="_top" class="ke-link"><span style="color: #000000;">한국보건의료연구원</span><span style="color: #000000;"> </span><span style="color: #000000;">전자우편</span><span style="color: #000000;"> </span><span style="color: #000000;">(safety@neca.re.kr</span></a><span style="color: #000000;">)</span><span style="color: #000000;">으로</span><span style="color: #000000;"> </span><span style="color: #000000;">신속</span><span style="color: #000000;"> </span><span style="color: #000000;">제출해야</span><span style="color: #000000;"> </span><span style="color: #000000;">합니다</span><span style="color: #000000;">.</span></p><p><span style="color: #000000;"> </span></p><div class="table-wrap"><table data-ke-type="table" data-ke-align="alignLeft" style="width: 100%;" border="1"><tbody><tr><td><span style="color: #000000;"> ① 사망 및 생명에 대한 위험이 발생한 경우에는 </span><span style="color: #000000;">2</span><span style="color: #000000;">일 이내</span><span style="color: #000000;">.</span><br><span style="color: #000000;">    </span><span style="color: #000000;">이 경우 최초 보고일부터 </span><span style="color: #000000;">5</span><span style="color: #000000;">일 이내에 상세한 내용을 추가로 보고해야 함</span><br><span style="color: #000000;"> </span><span style="color: #000000;">② 입원할 필요가 있거나 입원 기간을 연장할 필요가 있는 경우에 는 </span><span style="color: #000000;">15</span><span style="color: #000000;">일 이내</span><br><span style="color: #000000;"> ③ 영구적이거나 중대한 장애 및 기능 저하를 가져온 경우에는 </span><span style="color: #000000;">15</span><span style="color: #000000;">일 이내</span><br><span style="color: #000000;"> ④ 태아에게 기형 또는 이상이 발생한 경우에는 </span><span style="color: #000000;">15</span><span style="color: #000000;">일 이내</span><br><span style="color: #000000;"> ⑤ 그 밖의 부작용에 해당하는 경우에는 </span><span style="color: #000000;">20</span><span style="color: #000000;">일 이내</span></td></tr></tbody></table></div><p><span style="color: #000000;"> </span></p><p><span style="color: #000000;">○</span><span style="color: #000000;"> </span><span style="color: #000000;">평가</span><span style="color: #000000;"> </span><span style="color: #000000;">유예</span><span style="color: #000000;"> </span><span style="color: #000000;">이상</span><span style="color: #000000;"> </span><span style="color: #000000;">반응</span><span style="color: #000000;"> </span><span style="color: #000000;">보고</span><span style="color: #000000;"> </span><span style="color: #000000;">주체는</span><span style="color: #000000;"> </span><span style="color: #000000;">신청인</span><span style="color: #000000;"> </span><span style="color: #000000;">또는</span><span style="color: #000000;"> </span><span style="color: #000000;">해당</span><span style="color: #000000;"> </span><span style="color: #000000;">의료기술</span><span style="color: #000000;"> </span><span style="color: #000000;">사용자</span><span style="color: #000000;">(</span><span style="color: #000000;">실시의사</span><span style="color: #000000;"> </span><span style="color: #000000;">등</span><span style="color: #000000;">)</span><span style="color: #000000;"> </span><span style="color: #000000;">입니다</span><span style="color: #000000;">.</span></p>
<!-- -->
]]>
카페 게시글
자료모음 5
평가 유예 신의료기술 사용 중 이상 반응 보고 절차가 있나요? 이상반응 보고는 누가 하나요?
INSU
추천 0
조회 22
22.01.27 18:51
댓글 0
다음검색
