• 제목/요약/키워드: Monitoring Guideline

검색결과 243건 처리시간 0.025초

ICH-GCP와 선진 각국의 GCP 비교 (Comparison of Current GCPs on the Basis of the Contents in ICH-GCP)

  • 박혜연
    • 한국응용약물학회:학술대회논문집
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    • 한국응용약물학회 1997년도 추계학술대회
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    • pp.57-74
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    • 1997
  • To make a proposal for the revision of KGCP, ICH Harmonized Tripartite Guideline for Good Clinical Practice, which is on the stage of worldwide implementation, was compared with current GCPs of tripartite countries of ICH, namely USA, Europe and Japan as well as Korea. On the basis of the classification in ICH GCP, comprehensive comparisons among the corresponding articles of 4 regions or countries were made in the order of IRB / IEC, Investigator, Sponsor and Clinical Trial Protocol. Based on the comparisons of the contents in ICH-GCP with those in current GCPs, major suggestions for the revision of current KGCP can be made as follows. Firstly, the function of IRB / IEC needs to be strengthened for the initiation and continuation of clinical trial. Current 2-step approval system of IRB / IEC and Health Authorities requires to be converted into the system similar to that of developed countries. Secondly, sponsor's obligation needs to be tightened to control and assure the quality of clinical trial. Inspection of regulatory authorities should be made to perform during and / or after clinical trial, when it is necessary. In other words, sponsor should be made to establish written Standard Operating Procedures (SOPs) for all aspects of clinical trial including monitoring to ensure that trials are conducted and data are generated, documented, and reported in compliance with the protocol, GCP, and the applicable regulatory requirement (s). Besides, the provision of ‘Quality Control and Quality Assurance’ should be added to the protocol to establish the credibility of the result of the clinical trial.

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진동 감시용 위치 결정 센서의 위상오차에 대한 실험적 고찰과 비교평가 (The Experimental Study and Comparison on Usage of Vibration Monitoring Sensors for Positioning of Balancing on Rotating Machinery)

  • 오승태;유무상;봉석근
    • 한국소음진동공학회:학술대회논문집
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    • 한국소음진동공학회 2014년도 추계학술대회 논문집
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    • pp.314-320
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    • 2014
  • Field balancing is required in any kind of phase information for the determination location balancing mass toward a rotor unbalance mass. Phase or phase angle is a measurement of the relationship of how one vibration signal which relates to another vibration signal and is commonly used to calculate the placement of balance weight. In this paper, A right guideline shows the photo optical speed sensor as the external keyphasor is a very useful when diagnosing machinery vibration problems on considering a phase lag comparing to the laser optical speed sensor. Some experimental results generate the interesting phase errors when appling to a wrong conditions. So, Usage of photo optical speed sensor which is used primarily to measure the shaft rotating speed serves as a reference for measuring vibration phase information has effect on the placement of phase angle how it was misunderstood. This paper will help a right method to search for the position of balancing weight and serves as baseline for further measurements using low cost and much easier user convenience. It is concluded that the propose baseline is likely to be applicable to apply to the practical field balancing weight.

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진동 감시용 위치 결정 센서의 위상오차에 대한 실험적 고찰과 비교 평가 (The Experimental Study and Comparison on Usage of Vibration Monitoring Sensors for Positioning of Balancing on Rotating Machinery)

  • 오승태;유무상;봉석근
    • 한국소음진동공학회논문집
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    • 제25권2호
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    • pp.101-107
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    • 2015
  • Field balancing is required in any kind of phase information for the determination location balancing mass toward a rotor unbalance mass. Phase or phase angle is a measurement of the relationship of how one vibration signal which relates to another vibration signal and is commonly used to calculate the placement of balance weight. In this paper, A right guideline shows the photo optical speed sensor as the external KeyPhasor is a very useful when diagnosing machinery vibration problems on considering a phase lag comparing to the laser optical speed sensor. Some experimental results generate the interesting phase errors when appling to a wrong conditions. So, Usage of photo optical speed sensor which is used primarily to measure the shaft rotating speed serves as a reference for measuring vibration phase information has effect on the placement of phase angle how it was misunderstood. This paper will help a right method to search for the position of balancing weight and serves as baseline for further measurements using low cost and much easier user convenience. It is concluded that the propose baseline is likely to be applicable to apply to the practical field balancing weight.

생태수질기준설정을 위한 대상물질의 생태위해성 평가 (Ecological Risk Assessment of Chemicals of Concern for Initiation of Ecorisk-based Water Quality Standards in Korea)

  • 안윤주;남선화;김용화
    • 한국물환경학회지
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    • 제24권5호
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    • pp.592-597
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    • 2008
  • Current water quality standard (WQS) in Korea is based on the protection of human health, not considering the protection of aquatic organisms. Most of chemicals can be toxic to ecological biota as well as human. Health of aquatic biota is closely related to the human health via food chain, therefore ecological risk based-WQS needs to be developed to protect the aquatic ecosystem. In this study, we selected the 31 chemicals in the Project entitled 'Development of integrated methodology for evaluation of water environment'. The methodology for calculating water quality criteria was derived from the Australian and New Zealand processes for deriving guideline trigger value for aquatic ecosystem. The available ecotoxicity data were collected from US EPA's ECOTOXicology Database (ECOTOX), TOX-2000 Database, European Chemicals Bureau (ECB)'s International Uniform Chemical Information Database (IUCLID) and Environmental Protection Agency (US EPA)'s report 'Ambient Water Quality Criteria (AWQC)'. The aquatic toxicity data for the Korean species were selected for risk assessment to reflect the Korean water environment. The monitoring values were calculated from the water quality monitoring data four main Korean rivers. We suggested the order of priorities of chemicals based on ecological risk assessment. We expect that these results can be useful information for establishing the WQS for the protection of aquatic ecosystem.

연안침식방지사업의 해양물리분야 평가실태 및 개선방안 (Assessment and Improvement of Ocean Physics for Coastal Erosion Projects)

  • 탁대호;오현택
    • 수산해양교육연구
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    • 제28권4호
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    • pp.947-956
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    • 2016
  • This study analysed the documents of Sea Area Utilization Consultation of JongChun and ApHae located in West Coast of Korea and NaJeong located in East Coast of Korea in order to find out problems of site surveys and numerical simulations for coastal erosion projects of ocean physics, and suggested the improvement way to go. Current especially like wave-induced current is the one of the important external forces to handle coastal erosion but underestimated in the west coast. In case of east coast the various tests including wave-induced current were conducted but less efficient to find out the reasons of coastal erosion. The stiffness structure to protect coastal line like beach made the secondary erosion by using them without sufficient analysis for the erosion. In order to consult a Sea Area Utilization Consultation those are needed to review the scenarios for external forces such as wave and tidal currents, the site surveys for external forces, the net sediment analysis for years, the long periods of monitoring, and the guide line and revision of the rule for coastal erosion.

철도차량 차축 재료의 파괴특성 적외선열화상 모니터링 (Infrared Thermographic Monitoring for Failure Characterization in Railway Axle Materials)

  • 김정국
    • 비파괴검사학회지
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    • 제30권2호
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    • pp.116-120
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    • 2010
  • 차축과 차륜으로 구성되는 철도차량 윤축은 차량의 운행과 관련하여 안전과 직결되는 중요한 철도 부품의 하나이다. 본 연구에서는 철도차량의 차축 재료의 인장파괴거동에 대한 특성을 분석하였다. 20년 이상 운행된 전기기관차 및 디젤전기기관차의 차축 시편에 대하여 연장시험을 수행하였다. 인장시험 동안 시편의 파괴특성을 모니터링하기 위해 고속 적외선카메라가 사용되었는데, 인장시험 동안의 시편 표변의 온도 변화를 모니터링하여 온도 분포로부터 인장파괴거동을 설명하고 파괴모드를 규명하고자 하였다.

가축분뇨 병합처리 바이오가스화를 위한 설계 및 운전 기술지침 마련 연구(III) 설계 및 운전 지침(안) 중심으로 (A Study on Establishment of Technical Guideline of the Installation and Operation for the Efficient Bio-gasification Facility of Pig Manure and Food Waste(III): Design and Operation Guideline)

  • 이동진;문희성;손지환;배지수
    • 유기물자원화
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    • 제25권3호
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    • pp.99-111
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    • 2017
  • 본 연구는 유기성폐자원 (가축분뇨, 음식물류폐기물, 음식물류폐수 등)을 병합 소화하는 시설을 대상으로 적정 설계 기준치를 충족하기 위한 설계 및 운전 기술지침서 마련하고자 현장조사와 정밀모니터링을 실시하였다. 현장조사시 도출된 결과를 바탕으로 설계 및 운전 사항, 모니터링 항목 및 주기, 시운전 기간 등 바이오가스화 시설의 전반적인 가이드라인을 제시하였다. 초기 혐기소화 처리용량 설계시 유입 원료별 배출 특성을 고려하여 처리용량의 10~30 %의 여유율을 적용하였다. 공정별 설계 지침의 경우, 반입 및 전처리 설비의 유기물 반입 농도를 TS 10 % 이하로 제한하고 혐기소화조 운전시 저해요인 제한 농도을 제시하였다. 또한 병합기준 유기물부하율 $1.5{\sim}4.0kgVS_{in}/(m^3{\cdot}day)$, 소화가스 이용설비는 탈황 및 제습 방법, 호기액비화조의 적정 설계 운영인자 등을 제안하였다. 바이오가스화 시설의 운전인자는 pH (산발효조 4.5~6.5, 메탄발효조 6.0~8.0), 온도변화폭 $2^{\circ}C$ 이내, 휘발성지방산과 암모니아를 각각 3,000 mg/L 이하로 유지할 것을 권장하였다.

고품질화 바이오가스 이용 기술지침 마련을 위한 연구(III): 도시가스 및 수송용 - 기술지침(안) 중심으로 (A Study on Establishment of Technical Guideline of the Installation and Operation for the Biogas Utilization of Transportation and City Gas: Design and Operation Guideline)

  • 문희성;권준화;박호연;전태완;신선경;이동진
    • 유기물자원화
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    • 제27권2호
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    • pp.67-73
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    • 2019
  • 본 연구에서는 유기성폐자원의 바이오가스 생산 및 이용을 최적화를 위해 현장시설의 정밀모니터링과 시설별 에너지수지를 분석하고, 현장문제 해결방안에 대해서 조사하여 전처리시설 및 발전기 등의 설계 및 운전 가이드라인을 제시하였다. 고품질화 정제설비 운영에 잦은 고장 및 효율 저하를 해결하기 위해서는 가스전처리가 필요하며, 탈황, 제습, 탈실록산, 분진 처리, 휘발성유기화합물 등의 처리공정이 있다. 이 공정들은 고품질화 공정에서도 제거되는 물질들이기에 가스 전처리에서는 정량적 가이드라인은 제시하지 않고, 정성적 가이드라인으로 처리공간에 운영하도록 제시하였다. 특히, 분진, 실록산 및 휘발성유기화합물 등은 가스 전처리에서 제거되지 않으면 고품질화 공정의 잦은 고장의 주원인이된다. 바이오가스 고품질화 공정에 대한 설계 운전 가이드라인은 전체 가스 발생량의 90 % 이상 이용, 2계열화, 여유율 10 % 이상 감안 등이 있으며, 품질기준[메탄함량(프로판 포함) 95 % 이상]을 제시함. 또한 균등한 바이오가스 유입을 위해 가스균등조 설치, 보조연료 균등투입 제어를 위한 열량자동조절장치 설치, 가스압축과정에서 다량 발생하는 수분 제거를 위한 고품질화 후단의 제습장치 설치, 겨울철 설비의 결빙 및 효율 저하 방지를 위한 보온설비 설치, 특히 멤브레인 설비는 실내 설치 등을 제시하였다.

2021 Korean Society of Gastrointestinal Endoscopy Clinical Practice Guidelines for Endoscopic Sedation

  • Hong Jun Park;Byung-Wook Kim;Jun Kyu Lee;Yehyun Park;Jin Myung Park;Jun Yong Bae;Seung Young Seo;Jae Min Lee;Jee Hyun Lee;Hyung Ku Chon;Jun-Won Chung;Hyun Ho Choi;Myung Ha Kim;Dong Ah Park;Jae Hung Jung;Joo Young Cho;Endoscopic Sedation Committee of Korean Society of Gastrointestinal Endoscopy
    • Clinical Endoscopy
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    • 제55권2호
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    • pp.167-182
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    • 2022
  • Sedation can resolve anxiety and fear in patients undergoing endoscopy. The use of sedatives has increased in Korea. Appropriate sedation is a state in which the patient feels subjectively comfortable while maintaining the airway reflex for stable spontaneous breathing. The patient should maintain a state of consciousness to the extent that he or she can cooperate with the needs of the medical staff. Despite its benefits, endoscopic sedation has been associated with cardiopulmonary complications. Cardiopulmonary complications are usually temporary. Most patients recover without sequelae. However, they may progress to serious complications, such as cardiovascular collapse. Therefore, it is essential to screen high-risk patients before sedation and reduce complications by meticulous monitoring. Additionally, physicians should be familiar with the management of emergencies. The first Korean clinical practice guideline for endoscopic sedation was developed based on previous worldwide guidelines for endoscopic sedation using an adaptation process. The guideline consists of nine recommendations based on a critical review of currently available data and expert consensus when the guideline was drafted. These guidelines should provide clinicians, nurses, medical school students, and policy makers with information on how to perform endoscopic sedation with minimal risk.

활성 포렌식 기술을 이용한 좀비 PC 탐지시스템 모델 (Detection System Model of Zombie PC using Live Forensics Techniques)

  • 홍준석;니오박;박원형
    • 한국전자거래학회지
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    • 제17권3호
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    • pp.117-128
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    • 2012
  • 2009년에 발생한 7.7 DDoS(Distributed Denial of Service) 공격에 이어 2010년 3월 4일에도 주요 기관 사이트를 대상으로 대규모의 DDoS 공격이 발생 하였다. 악성코드 제작과 배포는 누구나 쉽게 좀비 PC를 양산할 수 있게 되고 DDoS 공격기법이 지능화 고도화되어 감에 따라서 DDoS 공격을 대응하는 보안담당자의 어려움은 점점 커져가고 있다. 정상 PC에서 좀비 PC로 감염되어 호스트에서 발생하는 변조내용을 분석하여 활성 포렌식 기술로 점검해야 하는 항목이 무엇인지 연구한다. 본 논문에서는 PC 보안관제시스템 구축 및 운영 방안에 대하여 다루었으므로 해당 시스템을 도입하려는 기업에게 좋은 기준서로 활용될 수 있다.