• Title/Summary/Keyword: 규정준수

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A Performance Evaluation Framework for e-Clinical Data Management (임상시험 전자자료 관리를 위한 평가 프레임웍)

  • Lee, Hyun-Ju
    • Journal of Internet Computing and Services
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    • v.13 no.1
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    • pp.45-55
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    • 2012
  • Electronic data management is getting important to reduce overall cost and run-time of clinical data management with the enhancement of data quality. It also critically needs to meet regulated guidelines for the overall quality and safety of electronic clinical trials. The purpose of this paper is to develop the performance evaluation framework in electronic clinical data management. Four key metrics in the area of infrastructure, intellectual preparation, study implementation and study completion covering major aspects of clinical trial processes are proposed. The performance measures evaluate the extent of regulation compliance, data quality, cost and efficiency of electronic data management process. They also provide measurement indicators for each evaluation items. Based on the key metrics, the performance evaluation framework is developed in three major areas involved in clinical data management - clinical site, monitoring and data coordinating center. As of the initial attempt how to evaluate the extent of electronic data management in clinical trials by Delphi survey, further empirical studies are planned and recommended.

Development of Linux based Real-Time Spectrum Analyzer for Puretone Audiometer (순음청력검사기를 위한 리눅스 기반 실시간 스펙트럼 분석기 개발)

  • Kang, Deok-Hun;Shin, Bum-Joo;Jeon, Gye-Rok;Wang, Soo-Geun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.12 no.6
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    • pp.2830-2839
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    • 2011
  • Because the puretone audiometer is an important medical instrument used to diagnose hearing loss, the IEC and ANSI has been published a specification with which audiometer should comply. This paper describes development of Linux based real-time spectrum analyzer which is dedicated to puretone audiometer. It can measure not only hearing level but also compliance of IEC standard for puretone audiometer such as frequency accuracy, harmonic distortion, pulsed tone, narrow band noise and linearity. We have verified our real-time spectrum analyzer through comparing to commercial product.

Study on domestic implementation of international treaty obligation regarding governmental supervision about national space activities (우주활동 감독에 관한 조약상 의무의 국내 이행을 위한 입법 방향 연구)

  • Shin, Hong-Kyun
    • The Korean Journal of Air & Space Law and Policy
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    • v.19 no.1
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    • pp.57-77
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    • 2004
  • According to the dispostions of 1967 Space Treaty, the contracting states should assume legal obligation to assure an authorization and continuing supervision with regard to the national space activities. Any space activities have to abide by the rules of international law as well as specified obligations set by the Treaty. Among several treaty obligations, International responsibility to be bome by the state, and the liability principles are deemed as major outstanding obligations which the state should takeinto account. While nation's first launch site is to be operational in a few years, korean government should assure that its national space activities, such as launching of space object, operation of satellites, etc. should be under governmental authorization and supervision. A legislative effort would be most desirable undertaking for this regard. Especially a specific legislation needs tobe studied forwith such authorization regime so that international responsibilty and the liability as to thelaunching of space object should be under the regulatory scheme. This study focuses upon the necessity of such legislation and proposes some major items and framework for the legislation

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Monitoring Country-of-origin Labels and Sanitation on the Meat Markets in Seoul, Korea (서울시 축산물(식육)판매업소의 원산지 표시실태 및 위생상태 모니터링)

  • Park, Jung-Min;Gu, Hyo-Jung;Jeong, Jong-Youn;Chang, Un-Jae;Suh, Hyung-Joo;Kang, Duk-Ho;Kim, Cheon-Jei;Kim, Jin-Man
    • Food Science of Animal Resources
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    • v.27 no.2
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    • pp.185-189
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    • 2007
  • Animals must be inspected prior to and after slaughter to make certain they are free of diseases and unacceptable defects. Since meats are potentially hazardous foods, they should not be accept if there are any signs of contamination, temperature abuse, or spoilage. This survey was aimed to monitor the current situation of country-of-origin labels and sanitation for the meat markets in Seoul, Korea. The markets were divided into groups as to 25 territories in Seoul and the size of markets (large size, medium size, and small size). In terms of size distribution, small butcher shops occupied the highest percentage. On the itemized suitability test of unpacked and packed beer in Seoul, most butcher shops showed good evaluation. However, labels indicating the grade, storage and cooking instruction for unpacked beef were not properly posted on the products. The results of monitoring sanitation conditions for butcher shops in Seoul showed relatively low suitability. Especially, there were serious lack of knowledge about wearing the sanitation clothings, caps, and shoes. The problem with food safety is so complicated that producers, consumers, merchandisers, the press, the government and the scholar should try to solve the problems altogether. Also, it is important to educate and provide them with correct understanding and information for food hygiene and safety.

Development of Stability Index for Vessel Operators Support System (선박 운항자 지원 시스템용 선박 복원성능 지수 개발)

  • IM, Nam-Kyun;HWANG, SooJin;CHOE, Hun
    • Journal of the Korean Society of Marine Environment & Safety
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    • v.24 no.1
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    • pp.1-9
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    • 2018
  • All ships should ensure stability in accordance with IMO regulations. However, GM is only used to determine ship stability because it takes a lot of time to validate all regulations. This is a problem given that the safety of vessels cannot be guaranteed, potentially leading to accidents. There is a need for a more intuitive and comprehensive method of confirming the stability of ships. This study developed a stability index that expresses ship stability in one value. An index equation is defined based on the 6 stability criteria for ships prescribed by IMO and the result of calculating the ship stability of a model ship. A stability index has been derived for each loading condition by applying the index equation to the same ship. It can clearly be seen that this stability index appropriately explains the criteria. In other words, it is possible to assess ship stability with one value and confirm whether the ship stability satisfies IMO regulations. This index will help masters and officers more easily and accurately check ship stability.

Forty years of the Outer Space Treaty : the problem inherent in governing the weaponization of the outer space (우주조약 체결 40년 : 우주의 군사적 이용 규율 문제)

  • Shin, Hong-Kyun
    • The Korean Journal of Air & Space Law and Policy
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    • v.23 no.2
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    • pp.207-223
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    • 2008
  • The launching of the Taepo-dong 1 on 31 August 1998 by the North Korea was the first case where the diplomatic protests was made against the flight, the purpose of which, the launching State claimed, consisted in space exploration and use. It is the principle regarding the freedom of space exploration and use, as included in the international treaty, that is relevant in applying the various rules and in defining the legal status of the flight. Its legal status, however, was not actually taken into account, as political negotiations leading to the test moratorium has been successful until present day in freezing the political crisis. This implies that the rules of the law lack the validity and logic sufficient in dictating the conduct of the States. This case shows that, in effect, it is not the rule but the politics that is to govern the status of the flight.

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Regulation of the Working Hour of Flight Crew in Germany (독일에서의 항공기승무원의 근로시간 규제)

  • Choi, Doo-Hwan
    • The Korean Journal of Air & Space Law and Policy
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    • v.20 no.2
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    • pp.235-251
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    • 2005
  • German working hour law of 1994(Arbeitszeitgesetz) provides maximum working hour as 8 hours a day and 48 hours per week. The law provides that minimum 11 hours rest-time is required between the end of a day's work and the beginning of the next day's work. Namely, the hour that the workers are put under commanding of the user is restricted within 13 hours per day. In the meantime, article 5, 7, 14, and 15 of the law have some letting the exceptional provisions regarding the working hour and rest-time of flight crew, and 2nd administrative order for the aviation transportation business owner, which is established based on such exceptional provisions(2.DV LuftBO), provides the working hour and rest-time of flight crew quite in detail. The administrative order is detailed quite regarding block time, flight working hour, and rest-time. So, it does not need to interpret additionally. Airlines in Korea should observe the both Labor Standard Act applying to general workers and Aviation Act focused on flight crew, so it is difficult that airlines manages working hour and rest-time of the flight crew efficiently. Therefore, it is desirable that our country refers to and considers adopting this legislation method of Germany which regulates working hour and rest-time of flight crew in detail in the 2.DV LuftBO.

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The Influence of Competitive Psychological Climate and IS Related Anxiety: The Role of IS Related Value Dissimilarity (경쟁적 심리 분위기와 정보보안 걱정의 영향: 정보보안 가치 차이의 역할)

  • In-Ho Hwang
    • The Journal of the Korea institute of electronic communication sciences
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    • v.18 no.4
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    • pp.649-660
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    • 2023
  • The study aims to identify the complex effects of information security (IS) environments and individuals' IS-related perceptions and value dissimilarity that negatively affect insiders' IS compliance activities. In detail, the study aimed to confirm the roles of prospective and inhibitory anxiety, and value dissimilarity in the process in which a competitive psychological climate negatively affects IS compliance intentions. The study obtained 387 samples from the firm's workers with IS-related regulations and verified the research hypotheses established using the AMOS 22.0 and Process 3.1 tools. As a result, the competitive psychological climate negatively affected IS compliance intention by increasing individual's IS-related prospective and inhibitory anxiety. In addition, IS-related value dissimilarity had an interactive effect with prospective and inhibitory anxiety and had a negative effect on IS compliance intention. This study has practical implications in terms of presenting information and values to be provided to employees to achieve internal IS goals and has academic implications in terms of applying the complex effects of IS-related anxiety and value dissimilarity.

Study on Development Roadmap of Technical Standards for Broadcasting and Communications Facilities (방송통신 설비 기술기준의 개발 로드맵 수립에 관한 연구)

  • Cho, Pyung-dong;Choi, Mun-hwan;Lee, Sang-mu
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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    • 2015.05a
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    • pp.795-798
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    • 2015
  • Technical standards for broadcasting and communications facilities are mandatory standard enacted by country and defines the essential matters the communication operators and related agencies should comply. Technical standards should be able to reflect the timely development of new communications services and technologies that it can provide the institutional framework for domestic adoption. This paper is to discuss the methodology for the development of a roadmap of technical standards and the direction of the revision of medium short-term technical standards.

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Research on Financial Regulations Related RPA(Robotic Process Automation) (금융회사 RPA(로봇자동화) 관련 규제 연구)

  • Han, Taek-Ryong;Lee, Kyung-ho
    • The Journal of Bigdata
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    • v.4 no.2
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    • pp.47-59
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    • 2019
  • Recently, the RPA (Robotic Process Automation) solution, which has been spreading in Korea and overseas, allows users to easily automate their tasks with the application GUI (Graphic User Interface), and the number of Korean financial companies which Implemented for automating their business is increasing now. However, as the major supervisory regulations that financial institutions must comply with are based on the existing traditional SDLC (Software Development Life Cycle), it is not proper to be directly applied to RPA that automates end-user works on the level of user's system interface. Therefore, in this paper, we organized the important financial supervisory rules and control items that should be considered for RPA implementation, then surveyed 24 financial companies which have implemented RPA for checking how they applied them. Finally, we would like to present the necessity of revision of related compliance.

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