• The Journal of Korean Medicine
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• v.17 no.1 s.31
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• pp.302-328
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• 1996

I . Objective and significance of the study To design a data acquisition chart, which facilitates data collection and analysis. The chart is also useful for solving problems that arise from personal variations in clinical symptoms and filling the knowledge base of an expert system. II. Content and scope 1. Collect the diagnosis knowledge of cerebrovacular diseases from doctors and analyze it. 2. Design a data acquisition chart. 3. Compare ODS and doctors with respect to their diagnosis results 4. Select patients who are determined to suffer from cerebrovascular diseases using CT(computed tomographic) scan, collect clinical data from them. III. Results and Application The chart be used for data collection and analysis in different medical hospitals, The results of data analysis facilitates collecting clinical data about other diseases and implementing the knowledge base. Also, the collected data serves as a tool for medical education, and cooperative diagnosis of oriental and western medical doctors.

• The Journal of the Korea Contents Association
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• v.13 no.4
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• pp.281-289
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• 2013

As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

• Journal of the Korean Data and Information Science Society
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• v.23 no.4
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• pp.643-648
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• 2012

There are lots of analysis to determine the relation between dependent variable and explanatory variables. Often the regression analysis is used to do this, and we can analyze the how much the explanatory variable can be related with dependent variable and how much the regression model can explain the data. But the validation check of regression model is usually determined by coefficient of determination. We should check the validation of regression coefficient with different methods. This paper introduces the method for validation check the regression coefficient using the jackknife regression and bootstrap regression in clinical data.

• Journal of the Korean Data and Information Science Society
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• v.23 no.4
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• pp.657-663
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• 2012

There are very small values and/or very big values which get out of the normal range for survey data in various fields. The reasons of occurrence for outlier are two. One of them is the error in process of data input and the other is the strange response of the respondent. If the data has outliers, then the summary statistics such as the mean and the variance produce misleading information. Therefore, researcher should be careful in detecting the outlier in data. In particular, it is very important problem for clinical fields because the cost of experiment is very high. This article introduce the Grubb test and Cochran test to detect outliers in the data and we apply this method for clinical data.

• 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.

• Journal of the Korean Data and Information Science Society
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• v.7 no.2
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• pp.283-287
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• 1996

본 연구는 중풍에서의 한의학의 풍부한 임상자료들에 대한 객관적이고도 논리적인 자료처리방법 및 변증으로부터 증형을 추론할 수 있는 통계적 방법을 연구하고자 한다. 중풍 전문의에 의해 수집된 65명의 환자들의 임상자료로부터 다변량 자료 분석의 하나인 판별분석을 이용하여 증후로부터 증형을 판단할 수 있는 수리적 판별모형을 구축하였다. 구축된 모형은 중풍 전문가 시스템을 개발하기 위한 기초가 될 것이다.

• Journal of Korean Ophthalmic Optics Society
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• v.9 no.1
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• pp.117-124
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• 2004

In this paper, we took the clinical data of Korean eyes and designed the schematic eye with the same optical properties of the real eye. In the design process, we took the clinical emmetorpia data of young Korean adults collected in the past and analyzed to get a basic specification of the real eye for the design of schematic eye. The purpose of design was for the schematic eye to have the same optical properties of real eye in spherical aberration and astigmatism.

• Proceedings of the Korea Information Processing Society Conference
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• 2010.11a
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• pp.161-164
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• 2010

식품의약품안전청은 산발적으로 흩어져 있던 임상시험 관련 정보를 통합하여 서비스하기 위한 방안으로 임상시험정보방을 개설하게 되었다. 임상시험승인현황 등 원시자료는 종이형태로 생산, 관리된다. 이를 통계자료로 활용하기 위해서 식품의약품안전청의 관련 시스템인 KiFDA 시스템에 입력을 하게 된다. 이 시스템에 입력된 데이터는 실시간으로 임상시험관련 웹서비스 시스템에 구축된다. 이때에 실시간 통계정보의 정확성이 무엇보다 중요하다. KiFDA 시스템의 데이터베이스의 실시기관명과 임상시험계획승인제도(IND) 승인리스트 원본의 실시기관명이 틀린 것도 있었다. 이는 동일한 실시기관도 화면에서는 서로 다른 실시기관으로 보일 수 있다는 것을 의미한다. 결국 통계자료가 부정확하게 표출되는 데는 이런 원인들이 있었던 것이다. 본 논문에서는 기존의 문제점을 개선하기위해 임상시험정보방의 효율적인 통계모델링을 설계하여 물리적 데이터베이스를 구축하였다.

• 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 korean veterinary medical association
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• v.37 no.8
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• pp.743-754
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• 2001

최근 대동물임상분야에서도 소의 번식장애에 대한 임상적인 실제에 있어 적용을 위한 신기법 개발 요구가 증대되고 있고 관련 연구자들에게도 번식장애에 대한 연구가 시급하게 요구되고 있는 실정이다. 따라서 필자는 최근 입수한 자료를 번역하여 우리 대동물임상 수의사분들에게 도움을 되기를 비는 마음에서 대한수의사회에 의뢰하여 긴급게재를 희망하였다. 참고로 이 자료는 일본 북해도 삿뽀로시 에베츠에 소재하는 낙농학원대학(酪農學園大學:Rakuno Gakuen University)에서 지난 5월 26일(토) 오전 8시 50분부터 오후 6시까지 대동물임상수의사들을 대상으로 한 교육세미나에서 발표된 것으로 도움이 될만한 주요한 내용만을 선별하여 소개하고자 한다. 또한 필자가 일본어로 된 자료를 번역하는 과정에서 우리말로 표현하는데 무리가 있는 부분은 알기 쉽게 평이하게 정리하였음을 서두에 밝혀둔다.