• 대한기관윤리심의기구협의회지
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• 제2권2호
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• pp.37-48
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• 2020

Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

• 한국산학기술학회논문지
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• 제20권9호
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• pp.397-404
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• 2019

무기체계 연구개발 시, 실제 환경에서의 기간, 안전, 비용 등의 사유로 시험평가가 제한되는 항목에 대해 M&S(Modeling and Simulation)를 활용하여 시험평가를 실시할 수 있다. 이때 시험평가용 M&S의 신뢰성(credibility) 확보를 위해 VV&A(Verification, Validation and Accreditation) 활동이 요구된다. 최근 무기체계의 연구개발 경향이 첨단화됨에 따라 M&S 활용과 이에 따른 VV&A 활동도 증가되고 있다. VV&A 활동이란 시험평가용 M&S가 실체계의 모습대로 구현되고, 사용 목적과 의도에 대한 신뢰성이 보장되었는지 검증(verification), 확인(validation)하여, 인정(accreditation)하는 것이다. VV&A 활동은 V&V(Verification & Validation)와 인정 활동으로 나뉜다. 국방과학연구소(이하, 국과연)에서 시험평가용 M&S의 VV&A를 수행할 시, V&V 활동을 수행하는 V&V에이전트는 국과연의 별도부서가 수행하고 인정 활동을 수행하는 인정(A)에이전트는 기품원이 수행한다. 본 논문은 현재까지 국과연에서 V&V에이전트로 수행한 시험평가용 M&S VV&A에 적용된 V&V 활동 프로세스 적립 결과를 소개한다. 이는 시험평가용 M&S의 개발과정에서 산출되는 각종 문서 및 개발 자료 등을 인정평가 항목의 관점에 따라 검증 및 확인을 하여, 인정판정 및 수락기준 충족여부를 판단할 수 있는 객관적인 근거 자료를 만들기 위해 수행한 프로세스이다.

• 디지털콘텐츠학회 논문지
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• 제17권5호
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• pp.329-338
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• 2016

최근 창조경제가 중요시 되면서 학습자 중심의 IP 교육이 각 대학별로 급속히 확산되고 IP 교육에 대한 관심과 요구가 급속히 높아지고 있는 반면 아직 이를 위한 교과과정 및 IP 교육 이수 인증(확인)에 대하여 충분히 갖추고 있지 못한 실정이다. 본 논문에서는 IP 교육 모듈을 제시하고, IP 교육 이수 인증(확인)에 대한 필요성과 인증 방안을 제시한다. 지식재산인력 및 교육의 필요성과, 현재 운영되고 있는 지식재산교육의 현황 및 분석, 지식재산 선도 대학 전체의 지식재산 강좌 추세를 살펴본다. 이어 국내교육인증제도인 교육인증제와 국가직무능력표준(NCS) 교육들에 대하여 살펴보고, 교과운영모델(안)으로서 IP교육 8개 과정 모형, 지식재산 표준교육과정 교육 이수체계 및 교육모듈을 제시한다.

• 보건의료산업학회지
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• 제9권4호
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• pp.1-12
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• 2015

Objectives : The aim of this research was to develop evaluation indicators that ensure safe services and enhance the quality of small-sized dental hospitals within local communities to prepare for the dental hospital accreditation system. Methods : Materials and data from a total of 460 respondents were analyzed after quality improvement indicators were formed by surveying experts and studying documents in Korea and abroad, and by conducting a survey from August 21, 2013 to September 30, 2013 for validation purposes. Results : Based on the results of factor analysis. all measured items appeared to be statistically significant with a factor loading score of at least 0.5, and the correlation between the factors all appeared to be high as well. The goodness-of-fit for the model also appeared to be within the recommended acceptance level. Thus, the proposed evaluation indicators for dental hospital accreditation developed in this study consisted of a total of seven major category factors and a total of 91 detailed items. Conclusions : Furthermore, the results suggest that the evaluation indicators can be used to improve the quality and to ensure the safe services of dental hospitals in local communities.

• 영어어문교육
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• 제15권2호
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• pp.71-92
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• 2009

Europass was established in 2005 by the European Parliament and the Council of Europe as a single framework for language qualifications and competences, helping citizens to gain accreditation throughout the European Community. In addition, the 1996 Common European Framework of Reference for Languages: Learning, Teaching, Assessment (CEFR) provides a common basis for language syllabi, curriculum guidelines, examination, and textbooks in Europe. This framework describes the required knowledge and skills, the cultural context, and the levels of proficiency that learners should achieve. In combination, Europass and the CEFR provide employers and educational institutes with internationally recognized standards. This paper proposes that current trends such as globalization and international mobility require a similar approach to accreditation in Asia. As jobs and workers become independent of national boundaries and restrictions, it becomes necessary to educate students as multilingual world citizens, using standards that are accepted around the world. It is suggested, therefore, that assessment models such as Europass and the CEFR, along with successful language teaching models in Europe and Canada, present opportunities of adaptation for the Korean education system. Finally, rigorous teacher training to internationally recognized levels is recommended, if Korea is to produce a workforce of highly-skilled, plurilingual world citizens.

• 대한본초학회지
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• 제38권6호
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• pp.61-71
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• 2023

Objectives : This study aimed to find out the future direction of accreditation system of Extramural herbal dispensaries (EHD) by comparing the current criteria of EHD and the existing Korea good manufacturing practice (GMP) regulations. Methods : Among the accreditation criteria of EHD, criteria of general herbal medicine was compared with the pharmaceutical GMP of Korea. The regulations of the accreditation of EHD and the regulations of KGMP were compared and organized with similar things based on the index of KGMP. All criteria from both were extracted for each element, classified into key-words and evaluated by dividing them into the same, similar one and no-matching. Results : Among the 189 criteria of KGMP, 77 criteria were consistent with the accreditation of EHD, and 15 criteria were similar. Based on the accreditation of EHD, 70.4% of the criteria were consistent or similar to KGMP. There were a total of 27 key-words only in the GMP criteria and not in the EHD one. Hence, a total of 25 key-words only in the EHD criteria and not in the GMP one. There were 12 similar key-words, and among them, there were 4 key-words in which accreditation of EHD was more specific than the KGMP. Conclusions : The criteria of general herbal medicine in EHD showed a similar or equivalent level of accreditation criteria compared to that of pharmaceutical GMP in Korea, and it ts believed that it should be considered at the current level to reflect the characteristics of herbal medicine.

• 간호행정학회지
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• 제22권5호
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• pp.437-447
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• 2016

Purpose: The purpose of this study was to conduct a grounded theoretical analysis on the hospital accreditation experience of head nurses in order to understand their behavior on the adaption of this new system. Methods: The participants were 8 head nurses with more than 3 years of experience. The data were collected through in-depth interviews using audiotape recording analyzed by the constant comparative method described in Strauss and Corbin's methodology. Results: There were 113 concepts, 26 subcategories and 12 categories identified through the open coding process. In the axial coding, the following paradigm model was proposed: 1) the causal conditions were 'hardware problem' and 'software problem', 2) the contextual conditions were 'vertical relationship', 'individual preference', and 'family support', 3) the intervening conditions were 'passive conditions' and 'active conditions', 4) the action/interaction strategies were 'leading role' and 'dependent role', 5) the consequences were 'positive acceptance' and 'negative acceptance', 6) the central phenomenon was 'difficult situation' and 7) the core category was 'leading in harmony'. Conclusion: The new system led head nurses having difficulties as the middleman between the hospital administration and general nurses, but they made a continuous effort to overcome and adapt to it through a number of strategies.

• 공학교육연구
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• 제14권4호
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• pp.48-61
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• 2011

국내외 기계공학분야 교육과정과 이수체계에 대한 고찰을 통하여 교육과정 및 이수체계 현황을 파악하고, 공학교육 내용과 지식의 논리적 구조에 근거한 합리적 이수체계 모델을 제시하여, 기계공학 프로그램의 운영 방향을 제시하고자 한다. 국내외 우수대학 기계공학 분야의 설계교육을 포함한 교육과정, 학문, 산업발전 동향을 고려하여 합리적 이수체계를 연구하였다. 특히 전면적인 선.후수 이수체계도입을 위한 방법을 연구하여, 교과 이수체계를 준수할 수 있는 제도적 방안을 제시함으로써 학생들이 공학지식의 논리적 구조에 따라 공학 관련 지식을 체계적으로 습득할 수 있도록 하고자 한다.

• 의학교육논단
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• 제15권1호
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• pp.1-8
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• 2013

Outcome-Based education (OBE) is reviewed from the institutional perspective. The demand for and international trends in OBE are briefly examined and several term related to OBE, especially educational objective and program outcomes (POs), are introduced. It is stressed that systems for continuous quality improvement and quality assurance should be established to ensure the maintenance of the OBE system. Because the criteria for accreditation contain a criterion regarding the quality assurance related to program outcomes, several critical issues are considered regarding the POs themselves and the reduction of the POs. The core value of OBE is not only to provide appropriate education services to students to prepare them with the minimum skills and abilities for advancing their professional service, but also to guarantee the quality of graduates. In addition, the educational program should be continuously improved by employing the evaluation results acquired during the operation of the OBE systems. It is certain that an OBE system is one important aspect of student-centered education.

• 식품과학과 산업
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• 제54권2호
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• pp.62-72
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• 2021

HACCP 인증업체의 자율관리 능력을 제고하고 관리가 미흡한 업체 등에 대한 집중관리 등 선택과 집중을 통한 관리가 필요하다. 더불어 스마트 HACCP의 확대, 보급을 통해 HACCP 운영의 효율성과 편의성을 향상 시켜야 한다. 이처럼 HACCP 제도의 내실화와 스마트화 뿐만 아니라 동시에 적용분야를 지속적으로 발굴, 확대하는 것이 우리나라 HACCP이 나아가야할 방향이다.