• Proceedings of the Korean Society of Computer Information Conference
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• 2014.01a
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• pp.429-432
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• 2014

국내 제약산업의 경쟁력을 제고시키기 위해서는 신약의 심사/허가 기간을 단축시켜 급변하게 변하는 글로벌 제약시장에서 경쟁 우위적 위치를 선점할 수 있도록 기회를 제공할 수 있도록 체계 개선이 시급하다. 신약허가를 위해서는 임상시험 결과에 대한 안전성과 유효성 등에 대한 심사가 수행되게 된다. 하지만 현재 신약허가를 위해서 제약사와 임상시험수탁기관(Contract Research Organization, CRO)에서 데이터 정보체계인 Domain, Variable 및 Parameter 등의 표준을 따르지 않고 다양한 유형의 임상정보데이터를 심사기관에 제출하고 있어 이로 인한 심사기간 증가와 심사업무 비효율성을 야기시키고 있다. 따라서 본 연구에서는 국제민간기구인 CDISC (Clinical Data Interchange Standards Consortium)에서 제정한 글로벌 임상데이터 표준인 CDISC 표준을 준용한 국내 임상시험정보관리 체계 (eCTD 시스템)및 의약품 전주기적 관리체계를 제시하고자 하며, 본 연구를 통한 기대효과로는 국제표준의 임상정보관리 인프라 구축으로 인한 국내 신약개발 및 해외 진출 환경을 마련하여 글로벌 시장선점의 기회를 제공할 수 있고, 규제기관 차원에서는 의약품 허가, 심사업무의 효율성 증가는 물론 전주기적 의약품 안전관리체계를 마련할 수 있을 것으로 사료된다.

• 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.

• 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.

• Proceedings of the Korean Society for Information Management Conference
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• 2017.08a
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• pp.104-104
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• 2017

연구 데이터란 과학적 연구에서 사용된 일차 자료와 연구자에 의해 직접 작성된 연구의 결과로서 수치, 문자, 이미지, 음성 등의 사실적 기록을 의미한다. 이 연구의 주제 분야인 의학은 잠재적 가치와 활용 가능성이 높고 공익적 성격을 가지고 있는 학문 분야로 의학 연구 데이터의 종류와 관리의 필요성을 통해서 그 가치와 공유 의미를 찾아보고자 한다. 또한 연구 데이터의 대표적인 임상 시험 기록과 연구 논문의 발표와 공유 현황에 대해서도 살펴보고 그 안에서 도서관의 역할이 어떤 것인가를 짚어보고자 한다. 의학 연구 데이터는 환자 진료기록, 건강 검진 기록, 임상 기록, 사망 기록, 임상 시험 기록, 유전체 정보, 연구 논문 등 그 종류와 형태가 다양하며 대용량인 경우가 많다. 의학 연구는 개인 정보보호와 윤리적인 문제 등 연구 수행 과정에서 어려운 점이 많은 성격을 가지고 있으나 질병 치료나 예방 나아가 인류의 건강과 직접적으로 관련된 학문 분야로 의학 연구 데이터의 보존과 공개, 공유를 위한 관리는 큰 의미가 있다. 의학 연구 데이터관리는 새로운 연구의 밑받침이 될 뿐만 아니라 중 저개발 국가의 연구자들에게도 큰 기회를 부여하여 세계적인 의학 발전에 기여할 수 있다. 또한 임상 시험 결과에 대한 은폐와 거짓 연구 방지에도 의미가 있어 미국뿐만 아니라 전세계적으로 학술 연구 논문 발표에 사용된 데이터는 등록하도록 규정하고 있다. 임상 시험 등록으로 공인된 사이트는 NIH의 ClinicalTrials.gov, ICTRP의 Primary Registry 등이 있으며, 우리나라에도 질병관리본부 국립보건연구원에서 관리하는 CRIS 등이 있다. 의학 연구자들은 연구의 시작부터 연구 데이터를 수집, 사용, 보존, 공유의 문제를 고려해야 하나 시간적 물리적인 문제 등으로 어려움을 겪고 있으며, 이를 지원하는 서비스는 도서관에서도 관심이 높아지고 있는 분야로 Virginia Commonwealth 대학 도서관과 Emory 대학 도서관 등에서 시도되고 있다. 이 서비스는 연구 과정에서 사서의 지원이 가능한 새로운 기회로 연구자의 데이터관리를 위한 단계별 스토리를 조직하고 DMP 작성 지원 및 교육 등을 통해서 학술 커뮤니케이션에서 새로운 역할자로 자리잡을 수 있을 것이다.

• Journal of the Society of Disaster Information
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• v.17 no.4
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• pp.778-785
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• 2021

Purpose: The study is to analyze the current status of international clinical trial information services related to COVID-19 and to find out the impact of disclosing activities of clinical trial registration on the medical and pharmaceutical industry. Method: To achieve the purpose of the study, this study analyzed the current status of 780 registered clinical trials for COVID-19 during March of 2020 by using regression analysis. Result: The analysis of clinical trial research registration information showed and proved its usefulness for the development of related new drugs, treatments, vaccines, predictive and prognostic diagnostic kits and treatments related to the COVID-19 (Corona 19) in the world. Conclusion: The study concludes and urges all medical and pharmaceutical companies to register their trials on CRIS and recommends utilizing this registered data to develop advanced drug to benefits all patients related to COVID-19.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.17 no.5
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• pp.137-142
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• 2017

The development of medical devices based on the theory of tranditional Korean medicine is increasing due to population aging and emerging demand for medical services. Various clinical trials are being conducted to ensure the clinical effectiveness of the developed medical devices, and the importance of systematic management of variously collected information in this process is increasing. In this paper, we designed and constructed the database that can systematically manage the medical information of the patient and the pulse measurement information in conducting clinical trials by using pulse analysis system which is a representative diagnostic method of traditional Korean medicine. The constructed database can be efficiently used for the verification of existing algorithms or developing new algorithms through the quality control of various information and measured data on clinical trials. It also has several advantages in the control of clinical data. The results of this study can contribute to the establishment of Korean medical device data standard for the construction of integrated database management system that can share information with different kind of pulse analysis system and other bio-signal measuring devices.

• The Journal of the Institute of Internet, Broadcasting and Communication
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• v.16 no.5
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• pp.205-212
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• 2016

Recently, researches for the integration and standardization of clinical data in the Western medicine and Korean medicine is in progress. If an integration of similar clinical data as well as heterogeneous clinical data is possible based on one standardization, we can able to derive implicit medical knowledge from integrated clinical data. In this paper, we implemented Korean clinical database based on internationally known CDISC standardization to efficiently store Korean clinical data and constructed E-CRF system for convenient data input in clinical sites. Furthermore, we showed example of an integration of Korean clinical data from 4 clinical sites. The results of our study will help to establish the foundation for the extraction of implicit medical knowledge from integrated clinical data. Also, our results may support efficient management through data integration, prevention of repetitive or unnecessary clinical trials, facilitation of collaborative study and convenient research through the distribution of refined clinical data.

• Journal of the Korean Institute of Intelligent Systems
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• v.22 no.3
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• pp.273-280
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• 2012

As changed the clinical environment, the interest on u-Healthcare service and systems has been increased. The ubiquitous healthcare(u-Healthcare) systems are constructed at the integrated environment that consists of various devices and systems basically such as personal health devices(PHDs) measuring body signals, information aggregators gathering the data transmitted from PHDs through wireless technology, and health information systems storing and managing personal health information transmitted from the information aggregators. International standards such as IEEE 11073 and HL7 have been specified for the interoperability of PHDs and health information systems, but the research on u-Healthcare systems that were developed and applied in the real clinical environment by adopting the standards was rarely conducted. Therefore, we developed an u-Healthcare system which can manage personal health information, such as blood glucose, blood pressure, and body composition, based on health information exchange standards. Moreover, we verified the stability of the developed system through clinical trial in patients with endocrine disease at the Kyungpook National University Hospital, and listed problems occurred during clinical trial and found their solutions.

• The Journal of Internal Korean Medicine
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• v.41 no.6
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• pp.959-966
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• 2020

Objectives: To examine the fundamental characteristics of interventional clinical trials registered in the CRIS (Clinical Research Information Service) database. Methods: We systematically analyzed the status of Korean medical interventions using the search function of the CRIS database. Results: From 2010 to January 2020, 267 Korean medicine-related clinical trials were registered with CRIS. The studies, which included many randomized trials (80.14%), focused primarily on demonstrating the effectiveness and safety of acupuncture and Korean herbal remedies. Most of these studies were government-sponsored and researcher-led clinical trials, but a few were company-sponsored trials. All trials were small and need improvement. Conclusion: This study reviews the current status of clinical trials in the field of Korean medicine and the basic data that can be used to create evidence-based Korean medicine.

• Journal of Digital Convergence
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• v.11 no.6
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• pp.213-219
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• 2013

The purpose of this study is to suggest a plan for which Medical Record Technician, who has main task as efficient creation and management of medical information, is changed successfully to health information manager in IT-based medical environment. According to this research objective, it carried out an analysis on future model(To-be) for being changed into health information manger in addition to analysis of the current situation for task as medical record technician. The subject materials of analyzing the present status included 1) state-exam subjects for medical record technician 2) qualification examination subjects for health information manger 3) analytical data of the current task for domestically medical record technicians 4) symposiums and educational topics for the recent 3 years in Korean Medical Record Association. Future-model(To-be) data included 'HIM Professional Roles in E-HIM (R)' suggested by AHIMA(American Health Information Management Association). Through a comparative analysis of these materials, a role of being needed currently medical record technicians' new entry was analyzed to be Business change manager, IT training specialist, Consumer advocate, Clinical alerts and reminders manager, and Enterprise application specialist.