• Title/Summary/Keyword: Quality Assurance protocol

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Comparison of Current GCPs on the Basis of the Contents in ICH-GCP (ICH-GCP와 선진 각국의 GCP 비교)

  • 박혜연
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1997.11a
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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.

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Adaptive MAC Protocol for Low Latency in WMSN (WMSN 에서 낮은 지연을 위한 적응적 MAC 프로토콜)

  • Kim, Seong-Hun;Lee, Sung-Keun;Jung, Chang-Ryul;Koh, Jin-Gwang
    • Journal of Internet Computing and Services
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    • v.10 no.2
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    • pp.161-169
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    • 2009
  • The development of Wireless Multimedia Sensor Networks(WMSNs) is getting realized in accordance with the increased demands to provide multimedia data transmission service such as CCTV movie, image chapter information, audio information based on wireless sensor network. It is very important to provide the differentiated quality assurance of service. In this paper, we propose a sensor medium access control protocol based on DSMAC, which provides differentiated Quality of Service(QoS) for delay. A proposed protocol is able to reduce the delay without increasing the energy consumption by adaptively changing the duty cycle according to the buffer occupancy. Simulation results show that the new MAC protocol performs better in terms of latency than S-MAC and DSMAC.

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Development and Evaluation of a Child Health Care Protocol for Child Day Care Center Teachers (보육교사를 위한 아동 건강관리 프로토콜 개발 및 평가)

  • Kim, Shin-Jeong;Yang, Soon-Ok;Lee, Seung-Hee;Lee, Jung-Eun;Kim, Sung-Hee;Kang, Kyung-Ah
    • Child Health Nursing Research
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    • v.17 no.2
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    • pp.74-83
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    • 2011
  • Purpose: The purpose of this study was to develop a child health care protocol for teachers in child day care centers. Methods: The ADDIE model with 10 Kid Keys was applied to develop this child health care protocol. All contents were developed through content validity test by 7 professionals and need assessment and evaluation by child day care center teachers. Results: This protocol consisted of 10 keys, as follows: "Health Examination/Growth & Development", "Practice of Health Life", "Management of Communicable Disease", "Negligent Accident", "Coping with Emergency and Transference", "Child Abuse", "Nutrition/Obesity", "Quality Assurance of Staff", "Parent Education", "Guidance & Supervision of Child Day Care Centers". The contents contained goals, objectives, teaching content, suggested activities for children, writing forms related to each subject, and self-evaluation sheet. Conclusion: This protocol can be practical and effective for child health care in child day care centers and it is hoped that it will be utilized in more child day care centers.

Proposal of Standard Method for the Analysis of Polycyclic Aromatic Hydrocarbons in Marine Sediments (해양퇴적물내 다환방향족탄화수소 분석을 위한 표준작업절차서 제안)

  • Lee, Hyo-Jin;Kim, Gi-Beum;Choi, Yoon-Seok
    • Journal of the Korean Society for Marine Environment & Energy
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    • v.14 no.3
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    • pp.163-175
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    • 2011
  • Though polycyclic aromatic hydrocarbon compounds (PAHs) in marine sediment has been produced by many colleges and institution in Korea, it is difficult to compare PAHs data in a study area with those in other areas due to the lack of confidence for the quality of data from the other organization. Therefore, we suggested the protocol for PAHs analysis in marine sediment through examining the method of PAHs analysis described in over twenty scientific papers and reports. When a known amount of 23 PAHs were spiked into a sediment and anlyzed following this new protocol, very good recoveries were obtained. In addition, for college and institution with their own method to analyze PAHs can keep producing PAHs data without exchanging to this new PAHs protocol, the method to get a full confidence through the QA/QC for the PAHs data produced by these organization is included to the protocol.

The Security Technology For QoS Assurance on Distance Learning Network (원격교육 망에서 QoS 보장을 위한 보안 기법)

  • 이근무;박수영
    • Proceedings of the Korea Multimedia Society Conference
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    • 2002.11b
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    • pp.690-693
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    • 2002
  • 차세대 인터넷에서 DiffServ 네트워크는 서비스 품질(QoS: Quality of Service) 제공을 위한 확장성이 높은 구조를 제시하고 있다. 차세대 네트워크에서는 음성이나 비디오 전송 같은 많은 응용들을 지원하기 위하여 QoS 보장 서비스가 필요하다. 차세대 인터넷에서 QoS 제공을 위하여 RSVP(Resource Reservation Protocol), MPLS(Multi-Protocol Label Switching), DiffServ 및 QoS 라우팅 등의 기법이 개발되고 표준화되고 있다. 원격 교육 역시 주로 인터넷이 주도하고 있다는 면에서는 QoS의 문제를 피해 갈 수 없는 것이다. 그러나, 국내에서는 이러한 QoS 능력을 안전하게 제공하기 위한 기법에 대한 연구가 거의 없는 실정이다. 따라서, 본 논문에서는 QoS를 안전하게 제공하기 위한 보안 기법을 DiffServ 네트워크를 중심으로 제시하고 원격교육에 적용시의 문제들을 고려하고자 한다.

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Design and experiment of the protocol using ASM2.0 : focusing on marine officers' mandatory reporting items (차세대 해상디지털통신기술 ASM2.0을 이용한 프로토콜 설계 및 실험 : 항해사의 의무보고 사항을 중심으로)

  • Kim, Kilyong;Kim, Do-yeon;Lee, Seojeong
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
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    • 2015.10a
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    • pp.43-44
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    • 2015
  • AIS-ASM is a one of the study to provide a variety of maritime safety information as well as ship's position and navigational information that is their own function since 2004. This study aims to reduce the marine officer's workload through automating marine officer's mandatory reporting items using the one of the next maritime digital communication technology (ASM2.0). For this purpose, we designed and experimented of the ASM2.0 protocol through analyzing a domestic regulation about passenger flight and AIS-ASM message.

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Advances in Radiation Oncology in New Millennium in Korea (21세기 방사선종양학의 전망:최근의 진보와 한국에서의 발전)

  • Huh, Seung-Jae;Park, Chan-Il
    • Radiation Oncology Journal
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    • v.18 no.3
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    • pp.167-176
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    • 2000
  • The objective of recent radiation therapy is to improve the quality of treatment and the after treatment quality of life. In Korea, sharing the same objective, significant advancement was made due to the gradual increase of patient number and rapid increase of treatment facilities. The advancement includes generalization of three-dimensional conformal radiotherapy (3D-CRT), application of linac-based stereotactic radiosurgery (SRS), and furthermore, the introduction of intensity modulated radiation therapy (IMRT). Authors in this paper prospectively review the followings: the advancement of radiation oncology in Korea, the recent status of four-dimensional radiation therapy, IMRT, the concept of the treatment with biological conformity, the trend of combined chemoradiotherapy, the importance of internet and radiation oncology information management system as influenced by the revolution of information technology, and finally the global trend of telemedicine in radiation oncology. Additionally, we suggest the methods to improve radiotherapy treatment, which include improvement of quality assurance (QA) measures by developing Koreanized QA protocol and system, regional study about clinical protocol development for phase three clinical trial, suggestion of unified treatment protocol and guideline by academic or research societies, domestic generation of treatment equipment's or system, establishment of nationwide data base of radiation-oncology-related information, and finally patterns-of-care study about major cancers.

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Development of pig welfare assessment protocol integrating animal-, environment-, and management-based measures

  • Renggaman, Anriansyah;Choi, Hong L;Sudiarto, Sartika IA;Alasaarela, Laura;Nam, Ok S
    • Journal of Animal Science and Technology
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    • v.57 no.1
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    • pp.1.1-1.11
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    • 2015
  • Background: Due to increased interest in animal welfare, there is now a need for a comprehensive assessment protocol to be used in intensive pig farming systems. There are two current welfare assessment protocols for pigs: Welfare Quality$^{(R)}$ Assessment Protocols (applicable in the Europe Union), that mostly focuses on animal-based measures, and the Swine Welfare Assurance Program (applicable in the United States), that mostly focuses on management- and environment-based measures. In certain cases, however, animal-based measures might not be adequate for properly assessing pig welfare status. Similarly, welfare assessment that relies only on environment- and management-based measures might not represent the actual welfare status of pigs. Therefore, the objective of this paper was to develop a new welfare protocol by integrating animal-, environment-, and management-based measures. The background for selection of certain welfare criteria and modification of the scoring systems from existing welfare assessment protocols are described. Methods: The developed pig welfare assessment protocol consists of 17 criteria that are related to four main principles of welfare (good feeding, good housing, good health, and appropriate behavior). Good feeding, good housing, and good health were assessed using a 3-point scale: 0 (good welfare), 1 (moderate welfare), and 2 (poor welfare). In certain cases, only a 2-point scale was used: 0 (certain condition is present) or 2 (certain condition is absent). Appropriate behavior was assessed by scan sampling of positive and negative social behaviors based on qualitative behavior assessment and human-animal relationship tests. Results: Modification of the body condition score into a 3-point scale revealed pigs with a moderate body condition (score 1). Moreover, additional criteria such as feed quality confirmed that farms had moderate (score 1) or poor feed quality (score 2), especially those farms located in a high relative humidity region. Conclusions: The developed protocol can be utilized to assess welfare status in an intensive pig farming system. Although further improvements are still needed, this study is a first step in developing a pig welfare assessment protocol that combines animal-, environment-, and management-based measures.

A pilot study of half-value layer measurements using a semiconductor dosimeter for intraoral radiography

  • Shun Nouchi;Hidenori Yoshida;Yusaku Miki;Yasuhito Tezuka;Ruri Ogawa;Ichiro Ogura
    • Imaging Science in Dentistry
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    • v.53 no.3
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    • pp.217-220
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    • 2023
  • Purpose: This pilot study was conducted to evaluate half-value layer (HVL) measurements obtained using a semiconductor dosimeter for intraoral radiography. Materials and Methods: This study included 8 aluminum plates, 4 of which were low-purity (less than 99.9%) and 4 high-purity (greater than 99.9%). Intraoral radiography was performed using an intraoral X-ray unit in accordance with the dental protocol at the authors' affiliated hospital: tube voltage, 60 kVp and 70 kVp; tube current, 7 mA; and exposure time, 0.10 s. The accuracy of HVL measurements for intraoral radiography was assessed using a semiconductor dosimeter. A simple regression analysis was performed to compare the aluminum plate thickness and HVL in relation to the tube voltage (60 kVp and 70 kVp) and aluminum purity (low and high). Results: For the low-purity aluminum plates, the HVL at 60 kVp (Y) and 70 kVp (Y) was significantly correlated with the thickness of the aluminum plate (X), with Y=1.708+0.415X (r=0.999, P<0.05) and Y=1.980+0.484X (r=0.999, P<0.05), respectively. Similarly, for the high-purity aluminum plates, the HVL at 60 kVp (Y) and 70 kVp (Y) was significantly correlated with the plate thickness(X), with Y=1.696+0.454X (r=0.999, P<0.05) and Y=1.968+0.515X (r=0.998, P<0.05), respectively. Conclusion: This pilot study examined the relationship between aluminum plate thickness and HVL measurements using a semiconductor dosimeter for intraoral radiography. Semiconductor dosimeters may prove useful in HVL measurement for purposes such as quality assurance in dental X-ray imaging.

Guideline on Acceptance Test and Commissioning of High-Precision External Radiation Therapy Equipment

  • Kim, Juhye;Shin, Dong Oh;Choi, Sang Hyoun;Min, Soonki;Kwon, Nahye;Jung, Unjung;Kim, Dong Wook
    • Progress in Medical Physics
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    • v.29 no.4
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    • pp.123-136
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    • 2018
  • The complex dose distribution and dose transfer characteristics of intensity-modulated radiotherapy increase the importance of precise beam data measurement and review in the acceptance inspection and preparation stages. In this study, we propose a process map for the introduction and installation of high-precision radiotherapy devices and present items and guidelines for risk management at the acceptance test procedure (ATP) and commissioning stages. Based on the ATP of the Varian and Elekta linear accelerators, the ATP items were checked step by step and compared with the quality assurance (QA) test items of the AAPM TG-142 described for the medical accelerator QA. Based on the commissioning procedure, dose quality control protocol, and mechanical quality control protocol presented at international conferences, step-by-step check items and commissioning guidelines were derived. The risk management items at each stage were (1) 21 ionization chamber performance test items and 9 electrometer, cable, and connector inspection items related to the dosimetry system; (2) 34 mechanical and dose-checking items during ATP, 22 multileaf collimator (MLC) items, and 36 imaging system items; and (3) 28 items in the measurement preparation stage and 32 items in the measurement stage after commissioning. Because the items presented in these guidelines are limited in terms of special treatment, items and practitioners can be modified to reflect the clinical needs of the institution. During the system installation, it is recommended that at least two clinically qualified medical physicists (CQMP) perform a double check in compliance with the two-person rule. We expect that this result will be useful as a radiation safety management tool that can prevent radiation accidents at each stage during the introduction of radiotherapy and the system installation process.