• 제목/요약/키워드: Good Clinical Practice

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유가사상(儒家思想)에 바탕을 둔 한의학에서의 의료윤리 (Medical Ethics based on Confucian Ideas in Eastern Medicine)

  • 김근우
    • 동의신경정신과학회지
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    • 제20권3호
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    • pp.149-168
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    • 2009
  • Objectives : This study aimed for attain to ideal aspects in medical ethics-clinical medicine, through researching doctor's ethics based on Confucian ideas, Methods : Research materials are datum of Confucian ideas included eastern medical books and the Confucian old books, Stand on above-mentioned, I investigate indispensable ethical condition clinical doctor must have in diagnose and treat. Results and Conclusions : 1. Combination of people-oriented ideas-Confucian and applicative learning-Eastern Medicine, doctor's principle mind is initiated and Confucian physician is the center of that. 2. For practice morality and ethics using the Confucianist's good character, Eastern medical doctor read and acquire the Confucian books. 3. Eastern medical doctor make an effort for application a kind love ideas(perfect religious scholarship ideas of Confucian), serve parents and country as for practice and sublimate into a kind love ideas through practice of integrity and the self-sacrifice. 4. Occasion to examine the female patient, emphasize good manners by Confucian ideas's sexual distinction 5. According to the doctor-doctor ethics, partnership is important due to Confucian faith and good manners 6. Confucian physician often effected by the people around patient and the protector of patient and criticize positive influence by these kind of peoples(傍人) when diagnose and treat. 7. Owing to Confucian's a notion of preferring a son to a daughter(男兒選好思想), come out the methods of convert a son into a daughter(轉女爲男法)-manipulation of sex distinction. this method is criticized aspect of medical ethics.

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Core Skill-TLP가 임상수행능력 향상에 미치는 효과 (The Effect of Clinical Performance Improving by Application of Core Skill-TLP)

  • 황현숙
    • 대한물리의학회지
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    • 제7권2호
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    • pp.231-239
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    • 2012
  • Purpose : The purpose of this study is to investigate the effect of clinical performance improved by the application of the Core-Skill TLP to students. Methods : The subject of the study were 48 students who are enrolled in the 2nd semester of the 3rd year in the department of physical therapy. In order to compare the difference in physical examination and intervention, clinical practice integration as well as interpersonal communication skills were measured before and after clinical performance experiments by using the questionnaire. Result : The results are as follows. There was an improvement after examination & intervention about mean 1.52(t=16.928, p=.000), in clinical practice integration 1.30(t=14.541, p=.000) and in interpersonal communication skills 0.86(t=9.510, p=.000). It shows the significant difference in statistics. Conclusion : According to these results, the Core-Skill TLP is proved as a good learning strategy and could be strongly recommended since it significantly improved physical examination & intervention, clinical practice integration and interpersonal communication skills.

보건진료원 직무교육 교과과정개선을 위한 연구 (A Study on Curriculum Development for CHPs)

  • 권명순
    • 한국보건간호학회지
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    • 제13권2호
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    • pp.26-44
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    • 1999
  • The study was done to improve the job training course for Community Health Practioners (CHPs) by evaluating the level of help that the training provided to the CHPs in carrying out their work and to analyze the management activities of the CHPs in order to develop a more effective CHP training program. The methodologies used in the study were a questionnaire survey. The survey results were analyzed using SPSS Windows. The study results are as follows. 1. The total average level of help from the job training(Theory. Practice and Field Practice) for carrying out the CHP work was found to be $3.04\pm.53$ (of a possible 4), which indicates a high level of help. The average for clinical practices was $3.16\pm.60$. for theory. $3.11\pm.40$ and for field practice. $2.84\pm.60$. 2. For the theory content of the job training courses. the help level was low in the area of mother and child health management/family planning with an average of $2.65\pm.62$ and in the area of health information system development with an average of $2.62\pm.83$. The reason for these deficiencies were. in order of frequency. few opportunities to apply learning. training content that was inadequate. training methodologies which were incongruent with content. improper training items and insufficient class hours. For the practice. the clinical work in rehabilitation/orthopedics departments and in ENT/Opthalmology departments had averages of $2.96\pm.86$ and $2.97\pm.80$ respectively. This low level resulted from the lack of direct experience. lack of sincerity during the practice time. lack of practice guidance. insufficient time and lack of practice equipment. in that order. For the field practice. the delivery management averaged $2.06\pm.90$ as the lowest help level. In this case 68% of respondents replied that there were no relevant reasons for this deficiency. 21% responsed that there was a lack of direct experience, 7%, a lack of practice guidance and 4.8%, insufficient time. 3. There were significant differences for several demographic variables when comparing the help level of the clinical courses (practice and Field Practice). A higher help level was reported by older nurses as compared to younger ones, experienced nurses as compared to scholarship nurses, and married over single. Also for nurses who had finished more other programs and were qualified or licensed in several areas the level was high. Although it was not statistically significant the level was higher if the work area was in a rural county, not a city, and if one had more recently completed the job training(P<,05). 4. Of the respondents 58.6% replies stated the period of job training for the CHP was adequate, but 51.7% reported that the period for theory courses was too short while an other 48.3% responded that it was sufficient. For practice locations, 50% responsed that it was good to practice in medical institutions(primary, secondary and tertiary) at the same time. While 48.3% agreed that doing theory and practice simultaneously was good, and 56.9% agreed that field practice should be done after completing theory and practice training. Hence, the development of new field practice guidelines suitable for changing environments of health management are required in place of the existing ones which were considered low in help level to the practical work of the CHPs.

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Development of Evaluation Items for Physical Therapy Clinical Practice

  • Seung-Hwa Jung;Joo-hee An;Seul-Ki Han;Dae-Sung Park;Cheong Hoon Kim
    • Physical Therapy Rehabilitation Science
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    • 제13권1호
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    • pp.71-77
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    • 2024
  • Objective: The purpose of this study is to present practice guidelines on what physical therapy students must learn during clinical training and how to evaluate them. Design: Design & development research Methods: A Delphi survey was conducted with 16 experts. Experts who participated in the study were asked to respond to 15 musculoskeletal system, 14 nervous system, and 12 physical factor therapy items through an online survey with a 5-point Likert score for each item regarding suitability and importance. Results: As a result of defining the core basic physical therapy skills that students in the Department of Physical Therapy must learn through clinical practice and in the process of evaluating them, there was a strong opinion that among the specific fields of physical therapy, evaluation items related to the musculoskeletal system, nervous system, and cardiorespiratory system were important. On the contrary, physical factor therapy showed poor results. Conclusions: In a previous study, opinions on the specialty of physical therapists were collected from current physical therapists, and the field of physical factor therapy was evaluated low. I think this reflects the perception that treatment using electricity has been commonly used in the field of physical therapy for a long time and does not require deep expertise among clinicians. Physical therapy clinical practice guidelines and efficient operation plans for clinical practice were presented. Through this, it can be usefully applied in hospitals where physical therapy students undergo clinical training in the future.

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

  • 장선미;이의경;박병주;허순임
    • 한국의료질향상학회지
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    • 제2권1호
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    • pp.86-109
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    • 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.

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국내 임상시험 실시기관의 의약품 임상시험 관리현황 분석 (Study on the Clinical Trial Practice of Drugs at the Designated Hospitals)

  • 이의경;장선미;허순임
    • 한국임상약학회지
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    • 제5권2호
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    • pp.33-49
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    • 1995
  • The purpose of this study is to understand present situation of clinical trials, and evaluate the preparedness of the desiRnated institutions to abide by GCP(Good Clinical Practice) standards during clinical trials. Survey on the status of clinical trials was conducted for the desienated 83 clinical trial hospitals, and response rate was $95.2\%$. The results showed that 39 hospitals have conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Most of them were trials on Phase III. Only $46.8\%$ of the institutions had sufficient human resources to perform the clinical trials. Institutions which established IRB(Institutional Review Board) 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 Places, respectively. Regarding supervision of the investigational drugs, less than 30 institutions designated pharmacist as a supervisor. In conducting clinical trials, $97.4\%$ of trials had high rates of prior consent of testees, but only part of them-$61.7\%$-gave written consent. The level of conducting GCP is found to be unsatisfactory. Institutions must build the appropriate infrastructure and government must prepare in order to protect testees' rights as well as to ensure validity of the results.

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일 대학 간호대학생이 지각한 중환자 간호 역량 조사 (Senior Nursing Students' Perceived Competence of Intensive and Critical Care Nursing)

  • 김진일;김두리;임효남
    • 한국간호교육학회지
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    • 제22권2호
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    • pp.115-124
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    • 2016
  • Purpose: The purpose of this study was to examine the degree of intensive and critical care nursing competence in senior nursing students. Methods: The research method for this study comprised a descriptive survey study with a convenience sample of 113 senior nursing students from one university. The instrument entitled ICCN-CS-1, which measures intensive and critical care nursing competence, was translated by the authors following WHO guidelines for translation process. The data were collected using ICCN-CS-1. Results: The mean score of intensive and critical care nursing was above the intermediate level. The competence indices of knowledge, skill and attitude/value were also above the intermediate level, which suggests that their competence is good. For two intensive and critical care nursing domains, the nursing students' mean score of clinical competence is higher than that of professional competence. The competence of intensive and critical care is also influenced by nursing students' satisfaction in their major and clinical practice as well as their confidence in clinical practice. Conclusion: The senior nursing students' competence of intensive and critical care nursing is above the intermediate level. A consideration of the influencing factors of satisfaction of nursing major/ICU practice and confidence of ICU practice is needed in intensive and critical care nursing education.

임상실습을 경험한 간호 대학생의 죽음의식과 좋은 죽음 인식에 대한 연구 (A Study on the Death Consciousness and the Awareness of Good Death in the College of Nursing Students who have experienced Clinical Practice)

  • 백소영
    • 디지털융복합연구
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    • 제16권10호
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    • pp.271-279
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    • 2018
  • 본 연구는 임상실습을 경험한 간호 대학생의 죽음의식과 좋은 죽음 인식을 파악하고 관계를 확인하고자 시도되었다. 자료 수집은 2018년 6월 1일부터 6월 15일까지 S시에 소재한 C대학의 3학년 111명, 4학년 94명인 총 205명을 대상으로 하였다. 대상자의 죽음의식과 좋은 죽음 인식정도 모두 보통수준이었고, 일반적 특성에 따른 죽음의식은 죽음에 대해 생각해본 경험에서(t=.559, p=.002), 좋은 죽음 인식은 죽음교육(t=.777, p=.018)과 죽음에 대한 이해정도에서 통계적으로 유의한 차이가 있었다(F=2.964, p=.033). 학년과 좋은 죽음 인식 간에는 정적 상관관계가 있었으나(r=.161, p=.021), 죽음의식과 좋은 죽음인식 간에는 상관관계가 없었다(r=-.71, p=.311). 본 연구의 결과로 임상실습을 경험한 간호 대학생들의 죽음의식과 좋은 죽음인식 정도와 죽음생각과 죽음교육의 중요성을 알 수 있었으며, 죽음의식과 좋은 죽음 인식 향상을 위한 간호교육과 관계 확인을 위한 반복연구가 필요하다.

Current Status and Strategies of the Efficacy and Safety Evaluation in Drug Approval Process

  • Park, In-Sook;Park, Chang-Won
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.2-1
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    • pp.22-24
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    • 2003
  • This presentation briefly will be introduced on new drug approval process and the review of safety and efficacy of drugs in Korea. First, we will present the regulation related to new drug registration [Regulation of the Efficacy and Safety Evaluation of Drugs, etc (Notification No. 2003-17), Standards for Toxicity Test of Drugs, etc(Notification 1999-61) and GLP Regulation for Nonclinical Laboratory Studies (Notification No. 2000-63)] and the regulation related to clinical trial [Guidelines to Clinical Study Authorization for Drugs (Notification No. 2002-65)] and [Korean Good Clinical Practice(KGCP, Notification No. 1999-67) Regulation]. (omitted)

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What is Evidence-based Dentistry?

  • Park, Livingstone Sang
    • Journal of Korean Dental Science
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    • 제3권2호
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    • pp.34-39
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    • 2010
  • In our daily practice, we think about the diagnosis of our patient and get into a situation wherein we have to make a clinical decision. Diagnosis and treatment come from the knowledge and experiences that each dentist should have, but sometimes, we can have doubts on our decisions. "On what evidence did I make such decision? Was that really right?" Drawing our attention these days as a possible answer to this question, evidence-based dentistry seeks to apply the best available evidence gained from the scientific method to medical decision making. To make a good decision, the strength of evidence is assessed. Specifically, randomized controlled trial, systematic review, and meta-analysis are considered the highest level of evidence; cohort study, case control study, case series, animal study, bench test, and biological plausibility follow. With the approach of evidence-based dentistry, we can make objective, scientifically sound clinical decisions. It is also patient-oriented, incorporating clinical experiences and stressing good judgments; thorough and comprehensive, it uses transparent methodology. That is the reason evidence-based dentistry can be better than other assessment methods when we make a clinical decision in modern dentistry.

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