• 한국콘텐츠학회논문지
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• 제16권5호
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• pp.601-611
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• 2016

구술심리주의의 확산, 국민참여재판의 도입 등 빠른 변화의 흐름 가운데 놓여있는 한국의 법정 환경은 구술주의의 단점을 효과적으로 보완할 수 있는 법정 프레젠테이션의 체계적인 도입을 필요로 하고 있다. 이에 본 연구에서는 한국의 법정 환경을 토대로 법정 프레젠테이션의 개념과 유형, 그리고 효용성을 정리 및 분석하였다. 또한 법정 프레젠테이션의 특수성을 고려하여 미국과 한국에서 가장 범용으로 사용되는 법정 프레젠테이션 도구들을 비교 분석하였다. 이러한 분석을 토대로, 한국의 법정 환경에 최적화된 프레젠테이션 도구가 갖춰야할 요소로서 1. 다양한 형태 매체의 삽입 용이성, 2. 그래픽 스타일 스펙트럼의 적절한 제한, 3. 그래픽 도구의 사용 편의성, 4. 시스템적 기능성 등의 요소를 제안하였다. 이와 같은 제안은 주장 전개와 내용 전달에 있어서 명료성, 정확성, 효율성 등을 강화할 뿐만 아니라 프레젠테이션 비주얼커뮤니케이션 측면의 심미성과 통일성을 증진하기 위한 것이다.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.

• 한국생물정보학회:학술대회논문집
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• 한국생물정보시스템생물학회 2005년도 BIOINFO 2005
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• pp.85-90
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• 2005

In this paper, firstly we report experimental results on applying information extraction (IE) methodology to the task of summarizing clinical trial design information in focus on ‘Compared Treatment’, ‘Endpoint’ and ‘Patient Population’ from clinical trial MEDLINE abstracts. From these results, we have come to see this problem as one that can be decomposed into a sentence classification subtask and an IE subtask. By classifying sentences from clinical trial abstracts and only performing IE on sentences that are most likely to contain relevant information, we hypothesize that the accuracy of information extracted from the abstracts can be increased. As preparation for testing this theory in the next stage, we conducted an experiment applying state-of-the-art sentence classification techniques to the clinical trial abstracts and evaluated its potential in the original task of the summarization of clinical trial design information.

• 소성∙가공
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• 제8권2호
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• pp.127-134
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• 1999

This study suggests the practical method which can reduce the lead time of the field trial and design of the dies. The virtual manufacturing, with which the die design is evaluated by computer analysis, reveals the impropriety of a design before die makings. Three methods for reducing the die making process occupying over 60% of the automotive development are like follows: First, the crack and wrinkle occurrence can be prevented by virtually adjusting the blank holding force and drawbead force with a computer simulation. Second, the parts which can not remove the forming defects in spite of the adjustment of forming parameters need to modify the part geometry or punch temporary shape. Third, the simulation before field trial, and field trial simulation can be effectively used in die design.

• 품질경영학회지
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• 제39권2호
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• pp.329-336
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• 2011

The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

• 동서간호학연구지
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• 제17권1호
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• pp.9-15
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• 2011

Purpose: The purpose of this study was to investigate recognition and knowledge regarding clinical trials, in particular, after a clinical trial education program (CTEP) among student nurses. Methods: A cross-sectional survey design of 215 student nurses at a university in Seoul was used with structured questionnaires. Results: Respondents had a high level of need for clinical trial and moderate levels in favorable image, safety, and need for education regarding clinical trial. The respondents who had participated in the CTEP felt the clinical trial more favorable and safer than those who did not. However, there were no significant differences in necessity of clinical trials and need for education regarding clinical trial between the CTEP participation and no participation groups. Respondents had a high level of knowledge about clinical trial, even though half of the respondents misunderstood that the physician can convince the subject to participate in clinical trial. There was no significant difference in knowledge level between groups. One third of the respondents had an intention to work in the area related to clinical trial because of aptitude or future prospect. Conclusion: The results of this study demonstrated that the CTEP might have an effect on student nurses' recognition rather than knowledge. The CTEP should be therefore developed targeting specific areas of misconceptions and recognition changes.

• 대한한방내과학회지
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• 제28권2호
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• pp.363-376
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• 2007

Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

• 천문학논총
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• 제24권1호
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• pp.65-81
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• 2009

We present the performance test results of VLBI Correlation Subsystem (VCS) trial product which was being developed for 1 year from August 2007. It is a core component of Korea-Japan Joint VLBI Correlator (KJJVC). The aim for developing VCS trial product is to improve the performance of VCS main product to reduce the efforts and cost, and to solve the design problems by performing the preliminary test of the manufactured trial product. The function of VCS trial product is that it is able to process the 2 stations-1 baseline, 8 Gbps/station speed, 1.2 Gbps output speed with FX-type. VCS trial product consists of Read Data Control Board (RDC), Fourier Transform Board (FTB), and Correlation and Accumulation Board (CAB). Almost main functions are integrated in the FTB and CAB board. In order to confirm the performance of VCS trial product functions, the spectral analysis, delay compensation and correlation processing experiments were carried out by using simulation and real observation data. We found that the overflow problem of re-quantization after FFT processing was occurred in the delay compensation experiment. We confirmed that this problem was caused by valid bit-expression of the re-quantized data. To solve this problem, the novel method will be applied to VCS main product. The effectiveness of VCS trial product has been verified through the preliminary experimental results, but the overflow problem was occurred.

• 대한한방체열의학회지
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• 제7권1호
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• pp.1-13
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• 2009

Purpose: To evaluate the hot flush relief efficacy of Yiseontang-gami in climacteric women with hot flushes, a vasomotor symptom. Methods: The 20 subjects who signing on the clinical trial written consent by self-will is registered this clinical trial after decided suitable by selection and exception standard, after take a medical experiment and checkup according to clinical trial plan. Registered subject should valuated by settled schedule after take the testing medicine(Yiseontang-gami)during thirty-day. The evaluating indexes of this trial are hot flush VAS, hot flush frequency, hot flush consistence time, sweating VAS, palpitation VAS, sleep disturbance VAS, MRS, MENQOL, PGA. Results: The results were as follows 1. 4 subjects dropped out of the clinical trial and 16 subjects completed it. 2. After Yiseontang-gami treatment, hot flush VAS, hot flush frequent, sweating VAS, Palpitation VAS, sleep disturbance VAS improved significantly. 3. After Yiseontang-gami treatment, hot flush consistence time was not improved significantly. 4. After Yiseontang-gami treatment, blood test value were not different significantly. Conclusion: In this clinical trial we consider that Yiseontang-gami is suitable treatment for the hot flushes and related symptoms.

• 한국응용약물학회:학술대회논문집
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• 한국응용약물학회 1997년도 추계학술대회
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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.