• 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.

• Korea Journal of Hospital Management
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• v.28 no.3
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• pp.1-14
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• 2023

Purposes: It is very important to establish a clinical data warehouse based on a common data model to offset the different data characteristics of each medical institution and for drug surveillance. This study attempted to establish a clinical data warehouse for Dankook university hospital for drug surveillance, and to derive the main items necessary for development. Methodology/Approach: This study extracted the electronic medical record data of Dankook university hospital tracked for 9 years from 2013 (2013.01.01. to 2021.12.31) to build a clinical data warehouse. The extracted data was converted into the Observational Medical Outcomes Partnership Common Data Model (Version 5.4). Data term mapping was performed using the electronic medical record data of Dankook university hospital and the standard term mapping guide. To verify the clinical data warehouse, the use of angiotensin receptor blockers and the incidence of liver toxicity were analyzed, and the results were compared with the analysis of hospital raw data. Findings: This study used a total of 670,933 data from electronic medical records for the Dankook university clinical data warehouse. Excluding the number of overlapping cases among the total number of cases, the target data was mapped into standard terms. Diagnosis (100% of total cases), drug (92.1%), and measurement (94.5%) were standardized. For treatment and surgery, the insurance EDI (electronic data interchange) code was used as it is. Extraction, conversion and loading were completed. R language-based conversion and loading software for the process was developed, and clinical data warehouse construction was completed through data verification. Practical Implications: In this study, a clinical data warehouse for Dankook university hospitals based on a common data model supporting drug surveillance research was established and verified. The results of this study provide guidelines for institutions that want to build a clinical data warehouse in the future by deriving key points necessary for building a clinical data warehouse.

• The Korean Journal of Health Service Management
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• v.12 no.4
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• pp.203-217
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• 2018

Objectives : This study aimed to investigate the clinical practice ability and satisfaction of clinical training of health-medical information management major students. Methods : The data were collected from 68 persons from students finished clinical training at medical record (information) team using self administered questionnaires. The data were analyzed using t-test, ANOVA and correlation with SPSS 22.0 version. Results: Performance of data collection, data management, and data analysis were analyzed in three areas of the job area. In terms of academic characteristics and correlation, they were not related to the level of satisfaction with the practical experience. Conclusions : Research on a virtuous cycle clinical practice program that analyzes the factors by assessing the satisfaction level of clinical practice in each area of health care information management will be conducted continuously.

• 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.

• Genomics & Informatics
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• v.11 no.4
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• pp.186-190
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• 2013

The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.

• Korean Journal of Radiology
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• v.23 no.9
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• pp.847-852
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• 2022

• Archives of Plastic Surgery
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• v.48 no.3
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• pp.295-304
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• 2021

Clinical photography is an essential component of patient care in plastic surgery. The use of unsecured smartphone cameras, digital cameras, social media, instant messaging, and commercially available cloud-based storage devices threatens patients' data safety. This paper Identifies potential risks of clinical photography and heightens awareness of safe clinical photography. Specifically, we evaluated existing risk-mitigation strategies globally, comparing them to industry standards in similar settings, and formulated a framework for developing a risk-mitigation plan for avoiding data breaches by identifying the safest methods of picture taking, transfer to storage, retrieval, and use, both within and outside the organization. Since threats evolve constantly, the framework must evolve too. Based on a literature search of both PubMed and the web (via Google) with key phrases and child terms (for PubMed), the risks and consequences of data breaches in individual processes in clinical photography are identified. Current clinical-photography practices are described. Lastly, we evaluate current risk mitigation strategies for clinical photography by examining guidelines from professional organizations, governmental agencies, and non-healthcare industries. Combining lessons learned from the steps above into a comprehensive framework that could contribute to national/international guidelines on safe clinical photography, we provide recommendations for best practice guidelines. It is imperative that best practice guidelines for the simple, safe, and secure capture, transfer, storage, and retrieval of clinical photographs be co-developed through cooperative efforts between providers, hospital administrators, clinical informaticians, IT governance structures, and national professional organizations. This would significantly safeguard patient data security and provide the privacy that patients deserve and expect.

• The Journal of the Convergence on Culture Technology
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• v.4 no.4
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• pp.387-392
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• 2018

Clinical trials are an important part of developing new medical devices or developing new drugs. However, it takes many time and expense to conduct clinical trials. In order to solve this problem, it define the standard format of the data collected in clinical trials in major countries and in Korea. Clinical trials are also underway in korean medicine to develop new medical devices. If it define the standards for the data we collect in clinical trials, there are likely to be a variety of ways to use them. If it collect and manage various clinical trial data as one standardized data, you will be able to draw various results. Based on these findings, we established a system for collecting and managing integrated data on clinical trials. And let's look at how to use it.

• The Journal of the Korea Contents Association
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• v.11 no.1
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• pp.350-356
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• 2011

The purpose of this study is to empirically examine how much the electronic clinical trial data management system actually enhances its efficiency. While the development of clinical trial markets highlights the significance of data management with increasing rate of adoption of electronic systems, its effects have not been fully supported with rigorous evidences. Particularly, the adoption rate of electronic clinical trial systems is low in domestic clinical trials markets. This study attempts to analyze the effect of the systems for reminding the importance of e-data management in clinical trials. The measurement indicator is experimented with the time related data collected from a multi-center clinical trial case. The result showed that the speed of the electronic clinical trial processes can be improved. The implication of this study lies in its first attempt to empirically analyze the effect of electronic clinical data management systems. Furthermore, application of the indicator in conjunction with electronic clinical trial processes is expected to facilitate strategic data management.

• Journal of KIISE:Computing Practices and Letters
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• v.15 no.8
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• pp.566-575
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• 2009

Clinical Data Interchange Standards Consortium (CDISC) developed global and platform-independent data standards to improve ineffective processes of clinical trial studies. Regardless of its objective toward global cooperation, the current version of the CDISC standard cannot describe clinical trial data in various languages for multi-national investigators or reviewers. This problem applies not only to tabulated datasets in Study Data Tabulation Model (SDTM) but also to extensible markup language representation of the datasets in Operational Data Model (ODM) instances. In order to address this issue, we propose to extend the current version of SDTM and ODM to collect clinical data for multi-national clinical trials. SDTM needs to have new special-purpose domain for multi-language representation purpose. Additionally, ODM is recommended to extend its XML schema using subtyping or type inheritance mechanism respectively. Our extension of SDTM and ODM enable to represent any granule of study data tabulation model or XML data entities to describe in efficient languages. This result will contribute to collect multi-language data easily for multi-national clinical trials.