• Journal of Digital Contents Society
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• v.16 no.4
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• pp.623-634
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• 2015

This research aims to perform an in-depth investigation about meanings and essence of working as clinical research nurses in local general hospitals. In order to interpret and reveal the meanings of role experience, data were collected from objects of 7 participants for 3 months. Data were analyzed by ethnographic research tools of Spradley. Themes conducted from this study were 'new experience about social learning process' and 'joys and sorrows through study participants ', 'lack of specialized learning course in nursing curriculums' and 'roles of general research planner', 'one's own work space' and 'proactive work environment that is relaxing and filled with consideration for others', 'hardship of being temporary employees. Clinical research nurses have experienced expansion of roles through new social learning processes. Conclusively, this study will provide useful basic data to develop new curriculum about clinical research nursing for nursing students and to improve working conditions for clinical research nurses.e purpose of this study is to design and implement a sign language dictionary for the deaf to understand information communication terminologies. When the deafs who have difficulties in communication use the internet, they can get help from this dictionary in accessing various types of information and expressing their intension. In order for the deaf to utilize the internet as efficiently as ordinary people, they must understand information communication terminologies first.

• Journal of the Korea Convergence Society
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• v.9 no.2
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• pp.19-32
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• 2018

The purpose of this study was to identify the convergence that resilience has on clinical performance ability and stress in clinical practice in order to prepare effective educational materials for clinical practice. The results showed that satisfaction of university life, satisfaction of nursing major and satisfaction of clinical practice had significant effects on resilience, clinical performance ability and stress in clinical practice. Also the correlation between the resilience and clinical performance ability of nursing students was positive(r=.510). And the correlation between the resilience and stress in clinical practice was negative(r=-.153). These findings indicate that there is a need to improve resilience of nursing students to promote the clinical performance ability and to lessen stress in clinical practice. The results should be reflected in the development of effective programs.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.21 no.1
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• pp.604-611
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• 2020

This study was undertaken is to improve the working conditions by improving the job satisfaction of clinical research nurses and clinical nurses involved in and conducting clinical trials. The survey was conducted from November 6 to December 6, 2017 for 100 nurses working in Seoul and Gyeonggi-do. The accumulated data were analyzed by frequency analysis, reliability verification, and t-test using the SPSS program. Our results reveal that job satisfaction was higher for clinical nurses (2.94 ± 0.609 points) as compared to clinical research nurses (2.89 ± 0.620 points). Also, the satisfaction level of salary received was higher amongst the clinical nurses than the clinical research nurses. Furthermore, although career decision was relatively lower for the clinical nurse than the clinical research nurse, the importance of job performance and job stability ranked high. Considering importance of the role of clinical research nurses in clinical trials, it is necessary to enhance their job satisfaction by improving the clinical trial environment such as appropriate treatment and professional role, and the working environment including remuneration, professional status, and administrative work to establish their jobs.

• Communications for Statistical Applications and Methods
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• v.2 no.1
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• pp.229-247
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• 1995

신뢰할만한 임상시험연구결과를 얻기 위해서는 통계학자가 임상시험연구의 준비단계에서부터 실험계획 및 연구의 운용, 분석은 물론 결과의 보고에 이르기까지 총체적으로 관여해야 한다. 의학전문가들과의 원활한 공동연구를 위해서는 통계학자들이 의학분야에서의 용어나 관례, 임상시험이 이루어지는 절차등에 대한 명확한 이해가 필요하게 된다. 이 논문에서는 임상시험에서 진행되는 제반문제에 대해 통계학자가 숙지해야 할 사항들에 대해 논의 하였다.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.159-184
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• 2021

The significance of the enactment of the 「Act On The Safety Of And Support For Advanced Regenerative Medicine And Advanced Biological Products」 is to break away from the regulation of the Pharmaceutical Affairs Act and expand patient treatment opportunities through a medical technology approach to regenerative medicine, which is essentially a medical practice called 'transplantation'. However, more than a year after the law was enacted, clinical study has not been activated, with not a single high-risk study approved by the Ministry of Food and Drug Safety being approved. The reason is that despite the legal purpose of expanding patient treatment opportunities, the data requirements for clinical study approval are set in connection with drug development despite the insufficient legal basis, making it difficult for many researchers to meet the data requirements. Prior to the enactment of the Act, submitted data for clinical study on cell therapy products within the Pharmaceutical Affairs Act were cosiderably exempted from quality and non-clinical test data, but with the enforcement of the Advanced Regenerative Bio Act, quality and non-clinical test data are required in accordance with pharmaceuticals when applying for approval of a clinical study plan. To rectify this, when considering the identity of clinical study on advanced regenerative medicine to expand treatment opportunities, recognize that there are limitations in connection with drug development. And it is necessary to preserve the identity of clinical study on advanced regenerative medicine, and on the other hand, in the case of drug product approval, clinical study results should be utilized while specifying usage requirements. Therefore, with the power of the market and the voluntary motive of the clinical researcher, it is necessary to prepare the necessary data by themselves rather than the basic requirements for clinical study approval.

• Proceedings of the Korean Society for Bioinformatics Conference
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• 2002.06a
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• pp.89-104
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• 2002

유전체연구사업단은 국내에서 발병 및 사망빈도가 가장 높은 위암과 간암의 퇴치를 목적으로 국가적 특목전략사업으로 연구를 추진하고 있다. 이와 별도로 보건복지부에서는 22개의 중요 질병별 유전체 연구센터를 전국적으로 추진하고 있다. 따라서, 연구가 성공적으로 진행되면 각 연구소에서 독자적으로 개발하여 제공하는 생명정보의 양은 거의 무한에 이를 것이다. 그러나 생명정보는 환자진료에 도움을 주기 위해서는 궁극적으로 임상정보와 함께 유기적으로 통합되어야 한다. 임상정보와의 통합을 위해서는 의료기관의 진료정보와 연구소의 생명정보가 연계되어 엄밀한 임상실험이 추가적으로 실시되어야 한다. 뿐만 아니라 생명정보학의 발전을 위해서는 연구대상의 임상정보가 공유되어야 한다. 유전체정보를 이용하는 생명정보학(Bioinformatics)은 각 국가마다 전략사업으로 간주하여 막대한 투자가 이루어지는 새로운 분야이다. 현재 선진국에서 개발 사용 중인 시스템의 연간 사용료가 고가이므로 국내 도입은 거의 불가능하거나 또는 매우 비효율적이다. 유전체 또는 생명정보의 임상활용 및 생명정보연구를 위한 임상정보 공유를 위해서는 우선 다음의 사항이 개발되어야 한다. 1) 다음과 같은 개별환자의 정보를 각 의료기관에서 제공 받아 저장 활용한다. - 진찰 및 임상소견, 수술기록, 경과기록, 검사결과 (임상병리, 해부병리, 방사선 등), - 영상정보 (X-ray, CT, MRI, 초음파, 전자현미경, 그래픽 등), - 환자개인기록(병력, 과거력, 가족력, 알러지 등), - 예방접종 기록 2) 각 연구소에서 첨단기술을 이용하여 개발되는 생명정보를 임상에 활용하기 위해서는 유전체연구센타와 병원간에 임상정보와 유전체 분석정보의 공유가 필수적으로 발생하게 됨으로, 유전체 정보와 임상정보의 통합은 미래 의료환경에 필수기능이 될 것이다. 3) 각 생명공학 연구소에서 사용하는 첨단 분석 장비와 생명공학 정보시스템의 자동 연계가 필요하다. 현재 국내에는 전국적인 초고속정보망이 가동되어 웹을 기반으로 하는 생명정보의 공유는 기술적으로 문제가 될 수 없으나 임상정보의 유전체연구에 그리고 유전체연구정보의 임상활용은 다양한 문제를 내포하고 있다. 이에 영상을 포함한 환자정보의 유전체연구센터와 병원정보시스템과의 효율적인 연계통합 운영을 위해 국내에서는 초기 도입단계에 있는 국제적인 보건의료정보의 표준인 Health Level 7 (textural information 공유), DICOM (image 및 wave 공유), 관련 ISO표준, WHO의 ICD9/10 (질병분류), LOINC (검사 및 관련용어), SNOMED International (의학용어) 등을 활용하여야 한다.

• The Journal of the Korea Contents Association
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• v.12 no.12
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• pp.714-720
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• 2012

With the help of information technology, it is the most important to collect clinical data correctly in clinical trials. For this, recently, in many pharmaceutical companies and Clinical Research Organizations (CRO) have tried to adopt an Electronic Case Report Form (eCRF) system. The eCRF system is a computerized system designed for collecting and managing clinical data in clinical trials. Although the eCRF is recognized as a significant system for clinical trials, until now there are no widely useable, due to the huge effort and expense at the initiatory stage of adopting eCRF system. In this study, we inquired the use of eCRF system developed for clinical trial at Korea Institute of Oriental Medicine. Especially, we focused on the time required for entering clinical data into the eCRF, hours of use, and the number of queries according to the time flow.

• Journal of the Korea Convergence Society
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• v.11 no.10
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• pp.181-186
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• 2020

In this study, an attempt was made to investigate the clinical reasoning of nursing students and to identify the factors that influence it. This study was held to grasp the learning ability related to core nursing competency for 297 3^rd and 4^rd grade nursing students. Results indicated that there was a significant difference when comparing clinical competence by grade(p=0.001). Also variables effecting clinical reasoning competence were Problem solving ability, Clinical Decision making ability, Clinical practice performance, and grade of nursing students were found to be significant (p,.001). Outcome of this study can be used as the basis for the development of various curriculums to enhance the clinical reasoning competence, in the future, research for this education development is expected to be needed.

• The Journal of the Korea Contents Association
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• v.17 no.11
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• pp.577-587
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• 2017

The purpose of this study was to test the effects of simulation practice education on clinical judgment, self-confidence, and clinical performance ability of nursing student. This study used a one group, pre-post test design. The subject of this study were 45 second grade nursing students who participated in the simulation practice education. Data were collected before and after the simulation practice education using the questionnaire. As a result of this research, the improvements of the clinical judgment, self-confidence, and clinical performance ability were statistically significant. Therefore, the simulation practice education has a positive effect on nursing students in terms of the clinical judgment, self-confidence, and clinical performance ability.

• Journal of the Korea Academia-Industrial cooperation Society
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• v.15 no.8
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• pp.5095-5108
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• 2014

The aim of this study was to compare the perceptions of the role performance of a clinical research coordinator (CRC) between the investigators and clinical research associates (CRAs). Data was collected using a structured questionnaire from 39 investigators and 68 CRAs in 4 hospitals from March 7 to November 30, 2011 and analyzed using descriptive statistics and a t-test. The investigators and CRAs were aware of the importance of CRC's role and they all gave the highest values for patients care management. On the other hand, the score of the role performance items showed perceptional differences between investigators and CRAs. Therefore, the development of detailed job descriptions and manuals will be needed to reduce the perceptional differences in the role performance of the CRC.