• Title/Summary/Keyword: Safety requirements

Search Result 1,733, Processing Time 0.036 seconds

Evaluation of Good Clinical Practice(GCP) Implementability at the Designated Clinical Trial Hospitals (임상시험 지정병원의 "의약품 임상시험 관리기준(KGCP)" 수행 가능성 평가에 관한 연구)

  • Jang, Sun-Mee;Lee, Eui-Kyung;Park, Byung-Joo;Huh, Soon-Im
    • Quality Improvement in Health Care
    • /
    • v.2 no.1
    • /
    • pp.86-109
    • /
    • 1995
  • Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

  • PDF

A Survey of the Residential Environment of Detached House of Elderly People (고령자가 거주하는 독립주택의 주거환경 실측)

  • Kim, Hyun-Jin;An, Ok-Hee
    • Korean Journal of Human Ecology
    • /
    • v.12 no.1
    • /
    • pp.85-94
    • /
    • 2003
  • With 106 detached houses where the elderly people lives, this study was conducted to perform a survey of their residential environment. The results of this study were summarized as follows: While the surveyed houses' safety, sanitation and convenience appeared to be positive, with respect to the conditions of location, 73.6% of the surveyed houses did not meet the requirements for comfort. The average area of each space indicated that the bed room was $12.09m^2$, the living room $14.38m^2$, the kitchen $8.96m^2$, the bath room $3.93m^2$, and the rest room $259m^2$. Then, 93.3% of the bed room had the doorsill. Also, 97.2% of the surveyed houses had retrievable space. The forms of the living room door were a hinged door(55.7%) and a sliding door(44.3%). The 43.4% of the finished material of the living room was wood which was highest. The cooking table forms of kitchen were mainly "ㄱ"-shaped(50.0%) and "ㅡ"-shaped(48.0%), and their average height was 815mm. The fuel used for kitchen was mainly the gas which accounted for 93.4%, but 95.3% of houses had no gas-warning devices. Most houses(77.4%) had an integrated type of bathroom and toilet. In addition, 63.2% houses had the stepped difference between the bathroom and other spaces. But they had no a sliding-prevention devices(not for 92.5%) or heating systems(not for 93.4%) in the bathroom.

  • PDF

A Study on the Counterplan for the Reinforcement of Port State Control - Primarily on the Korean Shipping Companies - (항만국통제 강화에 따른 우리나라 해운기업의 대응방안에 관한 연구)

  • Choi. U.;Shin, H.W.;Pyo, H.Y.;Choi, Y.R.
    • Proceedings of KOSOMES biannual meeting
    • /
    • 2003.05a
    • /
    • pp.41-58
    • /
    • 2003
  • A recent trend of global shipping industry adopting Port State Control (PSC) system is recognized as a proficient mechanism in preventing costal traffic accident and protecting marine environment. Disadvantages of Korean shipping companies in PSC inspection are unavoidable as Tokyo MOU imposed priority listed flag to Korea. Having stated above, appropriate research and prompt preparation in compliance with current PSC requirements for the Korean shipping companies have become an immediate need. The objectives of this study are : First, to review in understanding of PSC in overall and foundation of enforcement. Second. to study interaction of international treaties regarding PSC. Third, to compare practical compliance among the countries and to open up a case study on Korean shipping companies in adopting PSC. Last, to suggest direction to the Korean shipping companies the most proficient way in compliance with the current Tokyo MOU requirement. Korean flagged vessels have become prioritized target in PSC inspection as Tokyo MOU imposed priority listed flag to Korea due to high detention rate of its fleet. Disadvantage of a priority listed flag is a burden in its proficient fleet operation. This study suggests solutions to the disadvantages as below. : 1) Change shore management system, and provide continuous & quality education to crew members 2) Form a network in sharing PSC information among the Korean shipping companies 3) Form a centralized function in which government, Korean Shipping register and shipowners can treat problems in a prompt manner.

  • PDF

Calculated external pressure coefficients on livestock buildings and comparison with Eurocode 1

  • Kateris, D.L.;Fragos, V.P.;Kotsopoulos, T.A.;Martzopoulou, A.G.;Moshou, D.
    • Wind and Structures
    • /
    • v.15 no.6
    • /
    • pp.481-494
    • /
    • 2012
  • The greenhouse type metal structures are increasingly used in modern construction of livestock farms because they are less laborious to construct and they provide a more favorable microclimate for the growth of animals compared to conventional livestock structures. A key stress factor for metal structures is the wind. The external pressure coefficient ($c_{pe}$) is used for the calculation of the wind effect on the structures. A high pressure coefficient value leads to an increase of the construction weight and subsequently to an increase in the construction cost. The EC1 in conjunction with EN 13031-1:2001, which is specialized for greenhouses, gives values for this coefficient. This value must satisfy two requirements: the safety of the structure and a reduced construction cost. In this paper, the Navier - Stokes and continuity equations are solved numerically with the finite element method (Galerkin Method) in order to simulate the two dimensional, incompressible, viscous air flow over the vaulted roofs of single span and twin-span with eaves livestock greenhouses' structures, with a height of 4.5 meters and with length of span of 9.6 and 14 m. The simulation was carried out in a wind tunnel. The numerical results of pressure coefficients, as well as, the distribution of them are presented and compared with data from Eurocodes for wind actions (EC1, EN 13031-1:2001). The results of the numerical experiment were close to the values given by the Eurocodes mainly on the leeward area of the roof while on the windward area a further segmentation is suggested.

Development of Muki-purpose Marine Wastes Cleaning Systems for the Shallow Waters(PART I : Preliminary Conceptual Design) (천수용 다기능 해양폐기물 수거시스템 개발(PART I : 초기 개념설계))

  • Cho Yong-Jin;Moon Il-Sung;Shin Myung-Soo;Yu Jeong-Seok;Kang Chang-Gu
    • Journal of the Korean Society for Marine Environment & Energy
    • /
    • v.5 no.2
    • /
    • pp.50-61
    • /
    • 2002
  • This paper - following 'Functional requirement of marine waste cleaning ships and organization of the fleets'[1] - describes on the preliminary conceptual design procedure for the multi-purpose marine waste cleaning system for shallow waters. The working area of this system is Yellow Sea and part of South Sea of South Korea. As the first step, we determined the functional requirements including the daily target of waste collecting. Then, the preliminary conceptual design and general arrangements were carried out. In order to evaluate the safety and efficiency of this designed system, the stability check and the computer graphic simulation were carried out. Finally, the sea trial performance test of integrated systems in Yeosoo ports was performed and the designed system was shown its validity and effectiveness.

  • PDF

Fieldbus Communication Network Requirements for Application of Harsh Environments of Nuclear Power Plant (원전 극한 환경적용을 위한 필드버스 통신망 요건)

  • Cho, Jai-Wan;Lee, Joon-Koo;Hur, Seop;Koo, In-Soo;Hong, Seok-Boong
    • Journal of Information Technology Services
    • /
    • v.8 no.2
    • /
    • pp.147-156
    • /
    • 2009
  • As the result of the rapid development of IT technology, an on-line diagnostic system using the field bus communication network coupled with a smart sensor module will be widely used at the nuclear power plant in the near future. The smart sensor system is very useful for the prompt understanding of abnormal state of the key equipments installed in the nuclear power plant. In this paper, it is assumed that a smart sensor system based on the fieldbus communication network for the surveillance and diagnostics of safety-critical equipments will be installed in the harsh-environment of the nuclear power plant. It means that the key components of fieldbus communication system including microprocessor, FPGA, and ASIC devices, are to be installed in the RPV (reactor pressure vessel) and the RCS (reactor coolant system) area, which is the area of a high dose-rate gamma irradiation fields. Gamma radiation constraints for the DBA (design basis accident) qualification of the RTD sensor installed in the harsh environment of nuclear power plant, are typically on the order of 4 kGy/h. In order to use a field bus communication network as an ad-hoc diagnostics sensor network in the vicinity of the RCS pump area of the nuclear power plant, the robust survivability of IT-based micro-electronic components in such intense gamma-radiation fields therefore should be verified. An intelligent CCD camera system, which are composed of advanced micro-electronics devices based on IT technology, have been gamma irradiated at the dose rate of about 4.2kGy/h during an hour UP to a total dose of 4kGy. The degradation performance of the gamma irradiated CCD camera system is explained.

Non-memorizing authentication system using the preference words (좋아하는 단어를 이용한 암기하지 않는 패스워드 시스템)

  • Rim, Kwang-Cheol;Lim, Dong-Ho
    • Journal of the Korea Institute of Information and Communication Engineering
    • /
    • v.20 no.3
    • /
    • pp.565-570
    • /
    • 2016
  • User requirements for access and authentication increase daily because of the diversification of the Internet of Things (IoT) and social structures. The increase in authentication needs requires the generation of new passwords. Users want to utilize the same passwords for memorization convenience. However, system administrators request each user to use different passwords, as well as passwords that include special symbols. Differnet passwords and including special symbols passwords seem to exceed the tolerance range within your memorization skills. It fetches a very negative consequences in terms of password management. This paper proposes a preference symbol password system that does not require memorization by users. First, a survey is conducted to prove statistical safety, and based on this, an evolution-type password system that uses preference symbols is designed. Preference symbol passwords show superiority with respect to installation cost and convenience, compared with conventional non-memorizing password systems such as biometrics, keystrokes, and mouse patterns.

A Study on Security Evaluation for Mobile Web Services Message (모바일 웹서비스 메시지의 보안 평가에 관한 연구)

  • Lee, Seoung-Hyeon;Lee, Jae-Seung
    • Proceedings of the Korean Institute of Information and Commucation Sciences Conference
    • /
    • 2007.06a
    • /
    • pp.765-768
    • /
    • 2007
  • In this paper, the security evaluation method about mobile web services message is suggested in the method for improving the safety an reliability about the mobile web services message. In order that the goal of this paper is accomplished, the security threat and the security vulnerability which can be occurred in the mobile web services message are defined. The evaluation method for performing the security evaluation about the mobile web services message is defined. Also, the requirements for the mobile web services message security evaluation are defined. Finally, the evaluation framework for performing the mobile web services message security evaluation is constituted, and the evaluation scenario example is suggested. By using the mobile web services message security evaluation defined in the paper, before the mobile web services is deployed, the security threats and security vulnerability can be verified. Also, the countermeasure for the security threat and security vulnerability discovered in the verification result can be prepared. Therefore, the sorority and reliability about the mobile web services can be improved.

  • PDF

The Distribution and Application Method of Next-Generation Electronic Navigational Chart's Standards (차세대 전자해도 표준의 배포방안 및 응용방안)

  • Kim, Seong-Gon
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
    • /
    • 2017.11a
    • /
    • pp.115-116
    • /
    • 2017
  • In this paper, we propose a standardization strategy for next generation electronic navigational chart which can be classified as S-100 Universal Hydrographic Data Model, to accept various requirements arising from various marine information and services as well as support e-navigation service strategies. IMO uses the next generation electronic chart standard, S-100 as Common Maritime Data Structure. It means that a common data model is needed as a key element for realization of e-Navigation and also points out that a new ICT convergence paradigm is needed not only for marine safety but also for maritime information and services. this paper considers he model-based data representation and reference model in order to understand the content and use of the S-100 standard and also considers the interconnectivity and role of the ISO/TC211 standards, which are being used as base standards for profiling to develop S-100 standard. Finally, we look at what standardization items are required for standardization of next generation electronic navigational chart supporting multi-purpose and how they are used mutually.

  • PDF

Establishment of Room Based Database for Configuration Management in Nuclear Power Plant - Focusing on the Design Requirement and Facility Configuration Information - (원자력발전소의 형상관리를 위한 실(Room)기반 데이터베이스 구축에 관한 연구 - 설계요건 및 형상정보를 중심으로 -)

  • Shin, Jaeseop
    • Korean Journal of Construction Engineering and Management
    • /
    • v.19 no.6
    • /
    • pp.34-45
    • /
    • 2018
  • Nuclear power plant(NPP) is a large-sacle national infrastructure with total project cost of 77 billion dollars and period of 10 years or more. Moreover, since it is operated over 60 years, NPP is a facility closely related to national economy and public safety. Therefore, accurate information and consistent physical configuration should be maintained to enable accurate and economical decision making in NPP project process such as design, construction, operation, and decommission. Since NPP industry is more complicate and regulated than other industries, the importance of configuration management(CM) has been widely recognized in the early days. However, there were limitations in implementing systematic CM due to unclear purpose and subject. Therefore, this paper suggests a room-based database for CM in NPP reflects design requirements and facility configuration information.