• Proceedings of the Korean Society of Applied Pharmacology
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• 1997.11a
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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.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.29 no.4
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• pp.562-570
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• 2019

Objectives: Rapid Intervention Crews (RIC) are indispensable for rescuing firefighters who are lost or trapped. They are included in Disaster Scene Standard Operating Procedures. This study was conducted to examine the use of RIC at emergency scenes in South Korea. Methods: We conducted a nationwide survey of 4,913 firefighters in South Korea. The firefighters' experiences of use of RICs were assessed by asking, "How often are RICs available at fires?" Results: A full 40.8% of firefighters answered that they 'never' have RICs available at fires. Another 8.4% responded that they 'always' have RICs available, which is much lower than the rate among US firefighters (19.9%). RICs are available more often for firefighters in the capital area than for firefighters outside the capital area (13.4% vs. 5.1%, p<0.001). The larger the jurisdiction served, the more likely the firefighters were to have RICs available (p<0.001). Conclusions: These results imply that firefighters in South Korea are at risk. It is necessary to recruit personnel to improve the use of RICs and to explicitly include RICs in SOPs, training, and business plans.

• Journal of The Korea Institute of Healthcare Architecture
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• v.17 no.1
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• pp.23-32
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• 2011

Recently, with the advent of high risk infectious agent such as the Ebola virus, SARS, special research facilities dealing with such dangerous pathogenic are drawing attention gradually. Especially, this kind of facilities can be called BL4(Biosafety Level 4) facility. At the moment, Korean government is going to construct BL4 institute in order to handle efficiently such kind of pathogen. However, there are no proper design guidelines for BL4 facility. This paper proposes circulation system of BL4 facility on the basis of analysis of existing BL4 guidelines of Canada, and Korean BL3 facilities. The outcomes of this study are as follows. At first, functional areas of BL4 facilities have been divided into three categories according to the hazard level ; dangerous area, transitional area, and ordinary area. Secondly, circulation system of BL4 facility has been explored as a form of diagram according to the circulating subjects. These include human, laboratory animals, hazardous pathogen, equipments and cloth. This study has some limitations in that it lacks empirical evidences and concrete SOPs(Standard Operating Procedure). Despite of some weaknesses, it is expected to give some preliminary guidelines for the design of circulation system in BL4 facilities.

• The Journal of the Society of Korean Medicine Diagnostics
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• v.20 no.2
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• pp.51-65
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• 2016

Objectives This study was conducted to suggest a standard operating procedure (SOP) in order to improve the reliability of tongue-image analysis system. Methods An affecting-factors list was made, which may affect the diagnostic parameters of the tongue-image analysis system. They were sub-classified into two groups: controllable and uncontrollable. Only the controllable factors, which could affect the results and easily set-up, were included into the SOP draft. Affecting factors control experiment was performed to investigate the effects of controllable factors, whose influence on diagnostic parameters of the tongue-image analysis system is ambiguous: rehearsal for tongue extrusion; alignment of camera axis; and presentation of a guideline. Three subjects volunteered for this experiment. Each of three variables was implemented twice in a random order by two operators on the subjects. Finally, 96 tongue images obtained in the aggregate. The diagnostic parameter set as a primary outcome in this experiment was the percentage of tongue coating. Results All of the control variables were not significant in both operators; however, the presentation of a guideline was relatively more affect than two other variables. Interaction effects among the variables were also insignificant. Therefore, the presentation of a guideline was included in the final SOP and the other variables were not included. Conclusions We suggested the SOP which could be used for both experimenter and subject. Moreover, Each of the SOPs applied to various types of tongue-image analysis system should be developed in order to improve the reliability.

• Journal of National Security and Military Science
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• s.5
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• pp.131-172
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• 2007

Government duties in the cases of crisis are aimed at supporting efficient military operations in the fields of non-military affairs and resource mobilization, maintenance of government functions, and search for the public security of living during the war. In crisis, the government must change its functions into the total-war system with all resources available for the efficient performance of military operations, war economy, public safety and security as well as government continuance. The main contents of "Chung-Mu Plan" include the alternative measures to control the circulation of life necessities, emergency electricity, water and gas; recover public facilities from the disaster; and accommodate the wounded and refugees. Governments have practiced Ul-chi and ChungMoo exercises to improve government's management capabilities and master standard operating procedures including systematic distribution plans in the national and local level. However, such plans have not yet sufficient enough for the maintenance of public security of living. In addition to the conceptual ambiguity, major problems are the inappropriate system of the war economy, legal institutions, and administrative SOPs for the efficient maintenance of it. Thus, for the betterment of national crisis management system, the government should have the manual stated from every step and level dealing with crisis to the legal institutions. It is important to empower the National Emergency Planning Commission for the policy consistency and efficient/effective implementation. The comprehensive plans must have an integrated cooperative system of the central/local governments, military and civil society with actual practices and exercises for the maintenance of the public security of living.

• Journal of The Korea Institute of Healthcare Architecture
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• v.12 no.1
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• pp.49-59
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• 2006

According to the increase of demand for human organs such as kidney, heart, pancreas, joint, and cornea for therapeutic transplantation, the production of alternative organs based on Gnotobiotic Pigs gains a lot of concerns all over the world. However, it is not common to design and build Gnotobiotic Pigs' facility, and there are only a few those facilities and planning principles for them. Considering the situation above, this paper tries to develop planning guidelines for space organization and circulation system of standardized Germ Free Pig's facility on the bases of case analysis. The results of this study are as follows. At first, four swine farms including a Gntobiotic Pig's facility has been analysed from the point of space organization and circulation system. Secondly, the space zoning of Gnotobiotic Pigs' facility has been proposed into 5 groups : pigs' area, adminstration area, operating room and laboratory, service area, and mechanical area. Space components of each group have been presented also. Finally, circulation system of Gnotobiotic Pigs' facility has been explored from a operational point of view. This, also, includes human circulation, pig's circulation, and goods' circulation. This study has some limitations because it does not consider the SOPs(standard operational policies) of that facility to the fullest measure and does not suggest space area of each part, either. Despite of some weaknesses, it is expected that this study can give some useful guidelines for the design and planning of Germ Free Pigs' facilities.

• Journal of Advanced Navigation Technology
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• v.23 no.5
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• pp.408-414
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• 2019

We developed a surveillance tool for collision avoidance of unmanned aerial vehicles (UAVs) in urban areas. In our tool, users can visualize the safety distance on the actual 3D map of urban area. The estimated positions of UAVs are assumed to be obtained based on the long-term evolution (LTE) signals. The safety distance is defined to include two or more signals with bias. The safety distance calculation method used in this paper enables simulation similar to the actual urban areas where signals are frequently biased due to multipath. In the simulation, the parameters were set based on the measured values, and the change of the safety distance according to the number of faulty signals was simulated. As a result, increasing the number of faulty signals led to a longer safety distance as expected.

• CELLMED
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• v.11 no.1
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• pp.2.1-2.8
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• 2021

The clinical condition Amnesia causes difficulty in learning new information and the inability to recall past events. It is primarily concerned with recent memory loss. Majoon-e-Nisyan (MJN) is a polyherbal Unani formulation, present in a semi-solid form. It is widely used potent drug of the Unani System of Medicine (USM) for treating Nisyan (amnesia). In the present study polyherbal Unani formulation, MJN has been studied for its quality control and acute toxicity. Standardization (quality control) of drugs deals with drug identity, drug quality and purity determination. Standardization of MJN had been done as per the Unani pharmacopoeial parameters approved by World Health Organization (WHO) - Pharmacognostical parameters, Physico-chemical parameters, high-performance thin-layer chromatography (HPTLC), microbial load, aflatoxin, and heavy metals. Solvents and chemicals used in the study were of analytical grade and used instrument were calibrated. By conducting an acute oral toxicity study in rats, the safety of MJN was assessed. The limit test method of OECD guideline 425 was followed in the study. Results of standardization and standard operating procedures (SOPs) for preparation of MJN may serve as the standard reference in the future. The data generated in the study for the quality control of MJN proved the quality of formulation and shows that MJN is not toxic in rats following acute dosing up to 2000 mg/kg bw. The data obtained in the paper for MJN may be used as a standard guideline for preparation of the formulation which can save time, cost, and resources for future research endeavours.

• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.204-219
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• 2006

Objectives : This study is to report the proceeding of the project sponsored by the ministry of science and technology of Korea for the stroke study titled as 'fundamental study for standardization and objectification of differentiation and pattern identification of symptoms of Oriental Medicine in stroke'. Methods and Results : We works for clinical research and molecular epidemiology center and we are in charge of the development of case report form, education of the investigators, data entry, data validation, and analysis. In the process of this project, we need to development of standard operating procedures for development and education for the case report form. Conclusions : This study is to let researchers for Traditional Korean Medicine and clinical research know how to develop of case report form and standard operating procedures in clinical researches and maintain the resource document and data.

• Journal of Environmental Impact Assessment
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• v.22 no.6
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• pp.745-751
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• 2013

Environmental Specimen Banks (ESBs) have been established widely in the world since 1979 for monitoring long-term bio-accumulation of environmental pollutants. The ESBs perform the retrospective analysis of representative biological samples collected regularly and store them in cryogenic condition. In Korea, National Environmental Specimen Bank (NESB) was established in 2009. Since then, NESB had prepared the standard operating procedures (SOPs) for the seven kinds of specimens (Red Pine (Pinus densiflora), Common Carp (Cyprinus carpio), and etc.) for monitoring the effect of environmental pollution on the terrestrial ecosystem and river ecosystem. In 2012, NESB added Black-tailed Gull (Larus crassirostris)'s eggs to the list of the environmental specimen for monitoring marine environmental pollution. In this study, we sampled the eggs of the Black-tailed Gull on two islands (Baekryeongdo of the West Sea and Hongdo of the South Sea). Especially, we selected eggs which remained in the early stages of embryo development for certifying the consistent and stable monitoring for environmental pollutants in egg contents. However, it was not considered to classify an order of eggs per clutch in this study. It is known that the concentration variations of pollutants exist among eggs in one clutch. Therefore, it is needed to consider the positions of eggs in the laying sequences to meet the objective of bioaccumulation monitoring. We collected 30 eggs in each site but the amount may be insufficient to achieve storage target (over 2,000 g). Therefore, we need to consider an optimal sampling size.