• 응용통계연구
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• 제22권2호
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• pp.317-327
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• 2009

Adaptive Design은 임상시험 도중에 얻어진 자료에 대해 중간분석을 실시한 결과에 따라 임상시험의 중요한 요소들을 변경할 수 있도록 하는 디자인이다. 이러한 시험디자인이 치료적 확증 임상시험에 사용되는 경우, 중간분석은 임상시험에 참여하지 않은 전문가들로 구성된 독립적인 기구에 의하여 수행되어야 하며, 그렇지 않은 경우 bias(삐뚤림)를 유발시킬 수 있음을 여러 국제 가이드라인을 인용하여 지적할 것이다. 국제 가이드라인들은 중간분석의 독립적인 수행을 위하여 Independent Data Monitoring Committee(독립적 자료모니터링 위원회)를 둘 것을 권고하고 있다.

• 대한조선학회논문집
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• 제56권6호
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• pp.497-506
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• 2019

Literature survey was conducted on the 2013 Interim Guidelines for determining the minimum propulsion power to maintain the manoeuvrability of ships in adverse conditions. The International Maritime Organization (IMO) Marine Environment Protection Committee (MEPC) documents related with the Guidelines were reviewed. Compatibility of the present Guidelines can be checked by two different levels: (Level 1) minimum power lines assessment and (Level 2) simplified assessment. The IHS (Information Handling Services) sea-web data on the bulk carriers and the tankers, which were built after 2000, were used to examine the Level 1 assessment. KVLCC2 was used to examine the Level 2 assessment. Regarding the Level 2 assessment, effects of the adverse weather conditions, the added resistance due to waves, the wake fractions and the thrust deduction factors were discussed.

• 대한예방의학회:학술대회논문집
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• 대한예방의학회 1994년도 교수 연수회(역학)
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• pp.270-284
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• 1994

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately. the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. 'In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view. these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally. we discuss some important practical issues such as estimation following group sequential testing, anal ysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials. and the role of administrative analyses.

• 해양환경안전학회지
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• 제27권5호
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• pp.566-573
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• 2021

본 연구는 스마트 자율운항선박(Maritime Autonomous Surface Ship, MASS) 기술 개발 및 실증을 위한 산학 과제로서 목포해양대학교와 삼성중공업이 함께 참여한 연구가 안전하게 실시되어 질수 있도록 안전관리 절차서를 개발하였다. 본 연구에서는 국내 및 국제해사기구(International Maritime Organization, IMO)의 관련 가이드라인 및 해사 관련법 검토를 거쳐 안전관리 절차서를 개발하였다. 안전관리 절차서는 자율운항선박의 관련 해당 당국과 이해관계자들이 시스템 및 기반 시설에서 시험의 안전 및 환경 보호와 관련하여 적절하게 실시하기 위하여 국제해사기구에서 제시한 자율운항선박 시험을 위한 지침(MSC.1/Circ.1604, Annex : Interim guidelines for MASS trials)의 의거하여 개발 하였다. 개발된 안전관리 절차서는 당직체제로 운항 중인 선박에 항해보조기기로 탑재한 자율운항요소기술을 적용한 시스템의 해상 실증 시험을 위하여, 대한민국 연안의 해양환경보호와 항행 안전을 준수하면서, 관련 시스템의 시험이 안전하고 안정적으로 수행할 수 있도록 개발되었다.

• 한국항해항만학회:학술대회논문집
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• 한국항해항만학회 2019년도 추계학술대회
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• pp.137-138
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• 2019

국제해사기구(IMO)가 지난 제101차 해사안전위원회(MSC)에서 자율운항선박에 대한 해상시운전에 관한 임시지침을 회람문서(MSC/Circ.1604)로 채택하였다. 이 지침은 향후 자율운항선박의 해상시운전에 가이드라인으로 사용될 것이며 정부당국과 이해관계자들이 MASS의 안전 확보, 환경보호 및 시스템의 운용을 위한 인프라 구축에 사용될 예정이다. 이에 본 연구에서는 IMO에서 채택한 MASS 임시운항 시운전지침을 분석하고 실제 이해관계자들의 정부책임과 의무를 명확히 구분하여 해상시운전에 필요한 리스크 관리의 주요사항을 인적요소 관점에서 제시하고자 하였다.

• 대한조선학회논문집
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• 제43권5호
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• pp.529-537
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• 2006

International Maritime Organization (IMO) is planning to include the Alternative Assessment of the Weather Criterion in the new Intact Stability (IS) Code to be revised. In this study, the procedure of the model test in the Interim Guidelines was reviewed by carrying out the model test and analyzing the test results. For this purpose, RO/RO passenger ship whose ratios of breadth to draft and the height of weight to draft were above 3.5 and above 0.6 respectively was selected as a test ship. Drifting test and motion test in regular waves were performed to estimate the hydrodynamic heeling lever and roll-back angle. Motion tests in waves were carried out in the three wave steepness conditions to measure roll-back angle and examine the feasibility of so called, the Three-step method. Using the test data, satisfaction of the Weather Criterion was assessed for the test ship by using the alternative method and compared with the current method.

• 한국구조물진단유지관리공학회 논문집
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• 제20권6호
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• pp.56-64
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• 2016

해상교량의 선박충돌 문제는 기본적으로 선박의 충격력에 의한 부가 하중의 빈도를 추정하는 것이므로 특정한 수용 기준을 만족하도록 설계하는 것도 중요하지만 공용기간동안 이러한 충돌 위험의 증가분을 어떻게 유지관리 해야 하는지도 매우 중요하다. 본 논문에서는 인천대교를 대상으로 선박충돌 문제에 대한 중간점검을 위하여 관련 계획, 주경간장, 형하고 및 충돌 위험도를 검토하였다. 특히, 충돌 위험의 증가분에 대하여 근시적인 해결방안으로 관련 연구결과 및 운항관련 지침 등을 검토하여 최적화된 운항 속도를 8노트로 제시하였으며, 근본적인 해결방안으로 설계 단계에서 대상선박 및 통행량의 합리적인 예측을 위한 기본 절차를 수립하고 예측의 불확실성을 수용할 수 있는 확률론적 예측 기법을 제안하였다. 향후 선박충돌 관련 유지관리에 대한 추가적인 연구와 공용중인 다른 해상교량의 즉각적인 중간점검이 필요할 것으로 판단된다.

• 한국환경과학회지
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• 제26권5호
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• pp.639-649
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• 2017

Measurements of polychlorinated biphenyls (PCBs) were taken in surface sediments inside Seogwipo and Hallim Harbors of Jeju Island, Korea, to evaluate their distribution. These harbors typically have heavy ship traffic. The samples were collected three times (in June, October, and December, 2013). PCB concentrations in sediments from Seogwipo Harbor were higher than in those from Hallim Harbor, but both levels were very low, compared with those in other parts of the world. Sedimentary PCB levels had a strong correlation with organic carbon and fine granule mud content. PCB concentration values in the examined surface sediments were much lower than Sediment Quality Guidelines (SQGs) such as ER-L (Effect Rrange-Low), TEL (Threshold Effects Level) and ISQG (Interim Sediment Quality Guideline)-low value applied in countries, such as USA, Canada, and Australia. This suggests that the PCBs did not have significant biological effects on benthic organisms in the marine environment.

• 한국임상약학회지
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• 제26권2호
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• pp.181-186
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• 2016

Background: There has been on increasing emphasis on the importance of monitoring the safety of participants in a clinical trial to protect patients and maintain the integrity of the trial. The independent data monitoring committee (IDMC) has become common component of randomized clinical trials in recent years. Methods: It is important to consider the implications of different approaches that are being used in various countries. IDMC guidelines in Korea, US, and Europe were reviewed and compared to provide the objective, composition and operation of IDMC in detail. Results: IDMC is a group of experts in related subject are as who perform interim data monitoring to make a recommendation to the sponsor or organizer regarding appropriateness of trial continuation and the need for modifications of the trial. Independence of IDMC is preferred in order to minimize influence of factors unrelated to scientific, medical and ethical considerations that should underlie decision-making. Conclusion: IDMC has become an increasingly important component of clinical trials in recent years. Practical operating procedures need to be developed considering the future regulatory status of data monitoring committees.

• 한국마린엔지니어링학회:학술대회논문집
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• 한국마린엔지니어링학회 2011년도 전기공동학술대회 논문집
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• pp.3-6
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• 2011

The utilization of gas as ship fuel requires a new set of regulations by IMO and society of classification. Maritime Safety Committee(MSC) and the subcommittee Bulk-Liquids and Gases(BLG) in IMO developed "Interim Guidelines on Safety for Natural Gas-fueled Engine Installation in Ships(Res.MSC.285(86))" for the use of natural gas in internal combustion engine. According to the requirement of Res.MSC.285(86) for natural gas-fueled engine installations in ships, several parts of ships should follow safety criteria in terms of Fuel bunkering, Gas safe Machinery spaces, Gas Fuel Storage and etc. In this thesis, details of the IGF code shall be described and development of the IGF code in IMO shall be illustrated.