• The Korean Journal of Applied Statistics
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• v.22 no.2
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• pp.317-327
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• 2009

In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.

• Journal of the Society of Naval Architects of Korea
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• v.56 no.6
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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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• 1994.02b
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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.

• Journal of the Korean Society of Marine Environment & Safety
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• v.27 no.5
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• pp.566-573
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• 2021

In this study, safety management procedures were developed based on domestic and foreign guidelines and related maritime law to ensure the safe development and implementation of smart autonomous ship technology and Samsung Heavy Industry. The safety management procedure was developed according to the guidelines for (MASS) sea trials (MSC.1/Circ.1604, Annex: Interim guidelines for MASS trials), proposed by International Maritime Organization (IMO) for the relevant authorities and stakeholders of MASS to properly conduct tests of systems and infrastructure related to safety and environmental protection. The developed safety management procedure applies to the maritime demonstration test of a system applying autonomous navigation element technology mounted as a navigation aid on a ship operating under a watch system, while complying with the environmental protection and navigation safety of the coast of Korea.

• Proceedings of the Korean Institute of Navigation and Port Research Conference
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• 2019.11a
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• pp.137-138
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• 2019

The International Maritime Organization (IMO) adopted the Circular 101 (MSC / Circ. 1604) as an interim guidelines for MASS trials at the 101st Maritime Safety Committee. This guideline will be used as a guideline for the sea trials of Maritime Autonomous Surface Ships(MASS) in the future and will be used by government authorities and stake-holders to secure infrastructure for MASS safety, environmental protection and remote operation. The purpose of this study is to analyze the Interim Guidelines for MASS Trials adopted by IMO and to clearly classify the responsibilities and obligations of governments of stake-holders, and to present the main points of risk management necessary for maritime test operation from the perspective of human factors.

• Journal of the Society of Naval Architects of Korea
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• v.43 no.5 s.149
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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.

• Journal of the Korea institute for structural maintenance and inspection
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• v.20 no.6
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• pp.56-64
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• 2016

Damage of sea-crossing bridge by ship collision is related to estimate frequencies of overloading due to impact, and bridge accordingly must be designed to satisfy related acceptance criteria. Another important aspect is the management on increment of collision risk during the service period. In this study, related plan, main span length, air draft clearance and collision risk are analyzed for the interim assessment of Incheon Bridge focusing on the ship collision problem. In particular, for the increment of collision risk, the optimized navigation speed is proposed by reviewing the research findings and navigation guidelines etc. as a temporary expedient. Also basic procedure for reasonable prediction of target vessel and passage is established and probabilistic prediction method to embrace the uncertainty of the prediction is proposed as a fundamental solution. It is necessary to conduct further research on collision risk management and promptly carry out interim assessments of other marine bridges.

• Journal of Environmental Science International
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• v.26 no.5
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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.

• Korean Journal of Clinical Pharmacy
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• v.26 no.2
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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.

• Proceedings of the Korean Society of Marine Engineers Conference
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• 2011.06a
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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.