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AIM: To promote the Clinical Data Inter-change Standards Consortium (CDISC) standard in clinical trials and promote the standardization of clinical trial data. METHODS: To combine the implementation guide of Analysis Data Model (ADaM) and common problems of actual data, and to introduce the application of analytical data model ADaM in the safety of bioequivalence trails of generic drugs. RESULTS: For different types of clinical trial data, according to various situations that may occur, a safety analysis data set that meets the standards was generated. CONCLUSION: Under the background of the continuous development of generic drugs in China and the low degree of standardization of clinical trial data, the use of CDISC standards in clinical research can promote the standardization of clinical trial data, and can also shorten the time of statistical analysis and accelerate the process of drug development.
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Data acquisition is one of the key links that influencing the quality of clinical research.Electronic data capture system (EDC) embodies the advantages of saving time,manpower and material resources and improving efficiency and reliability by data acquisition.CDISC has established worldwide industry standards to support the electronic acquisition,exchange,submission and archiving of clinical research data.The application of CDISC standards to EDC system is favorable in ensuring the validity and standardization of clinical data.This paper takes the Oracle's OC/ RDC (Oracle Clinical / Oracle Remote Data Capture) system as an example to discuss the application of CDISC standard to EDC system from the two aspects:direct application and indirect application.We suggest that data collection should be taken into account during the design phase of a clinical trial,and the CDISC standard be applied at the CRF design stage.A design for eCRF takes time and effort by the combination of EDC system and CDISC standard,while thoughtless design may collect the wrong data.Therefore,it is suggested that a specialized personnel should be put in charge of eCRF design and maintenance during the operation of EDC system,and a set of standardized eCRFs based on CDISC standard and standard operating procedures should be built in one organization.
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On the basis of summarizing the general situation of current internal and external network construction of hospitals,the paper introduces the main hidden dangers of hospital network security,puts forward internal and external network security management measures,and elaborates the internal and external network security construction principle,network topology structure,and network construction achievements of the First Affiliated Hospital of Guangxi Medical University.
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In this article, a new TCM clinical trial of phaseⅢ was served as an example of application of Clinical Data Interchange Standards Consortium (CDISC). It briefly introduced seven data acquisition modules commonly used in clinical research of new traditional Chinese medicine, namely demographics, subject characteristic, clinical event, medical history, questionnaire, laboratory inspection and adverse event. It also introduced the process of transferring the above modules to Study Data Tabulation Models (STDM), and discussed the feasibility and some issues that required attention of CDISC application in clinical research of new traditional Chinese medicine.
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While there is an advantage to be able to directly utilize some research database of medical information must solve several problems. It also includes support for international standardization, led by computerized system validation, and CDISC. We should countermeasures with epidemiological studies using SS-MIX standardized storage, in anticipation of its application to clinical trials in the near future in Japan. (Jpn J Pharmacoepidemiol 2013；18(1)：35-39)
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BACKGROUND: A questionnaire survey was performed to perceive the problem of the current medical insurance reimbursement system for laboratory tests referred to independent medical laboratories; then, we intended to find a way to improve the reimbursement system. METHODS: Questionnaires were distributed to 220 independent medical laboratories and 700 laboratory physicians from July through October 2005. Frequency analysis was used to analyse the replies from 109 respondents to 25 questionnaire items regarding the current medical insurance reimbursement system for referral tests, problems with the system, and suggestions for the improvement of the system. RESULTS: Among the 109 respondents to this survey, 49 (45.8%) considered the current reimbursement system to be unsatisfactory, while only 16 (15.0%) answered satisfactory. The problem was that the referral clinics-not the laboratories that performed the tests--would first receive their reimbursement for the laboratory tests from Health Insurance Review Agency (HIRA) and then give a portion of the laboratory test fees to the independent medical laboratories after the deduction of administrative fees. They (62.5% of the respondents) would prefer a separated reimbursement system by which the referral clinic-as well as the independent medical laboratory-would receive their reimbursement directly from HIRA through an Electronic Data Interchange (EDI) system. In this new system, 34% of the respondents expected the quality of the laboratory tests to be improved; however, 41.6% answered that the income of the referral clinic is expected to decrease. CONCLUSIONS: For the improvement of the medical insurance reimbursement system, the administrative fee for the referral clinic and the test fee for the independent medical laboratory should be reimbursed directly to the respective organizations. These changes could be made possible with the proper analysis of medical costs and the development of an effective EDI reimbursement system.
Subject(s)
Female , Humans , Male , Clinical Laboratory Techniques/economics , Insurance, Health, Reimbursement , Korea , Laboratories, Hospital/economics , Surveys and QuestionnairesABSTRACT
Objective To develop a pathology information system and provide a pathology testing platform with digitalization,normalization and optimization. Methods Based on the principal and requirement of information engineering theory to analyze the profession,flow-sheet management and data needs of pathology information system. The pathology examination and related testing were analyzed mainly,included some special requirements in installation of work position,quality control,cost management,which were transformed conceptual and logical structure of database and realized physical composition on Oracle database. The reciprocal software codes were researched by PB program,which can build database in servers and install application software in front end computer. Results The system that was specified the components of the clinical data entry,pathology examination registry,clinical document repository,EMR application server and the e-node accessing server. The system was tested and the result indicated that the system was an effective and scalable. Conclusion The pathology information system can be not only used realize the sharing of EMR documents across multiple hospital,but also support the collection clinical data within hospital clinical system integration.
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Traditional tele-consultation platform adopts point-point communication.With the development of internet communication and dynamic service page technology,the data transmission of medical images through internet becomes possible.This paper discusses the system structure of remote medical images consultation platform based on internet communication and analyzes the data management and communication mode adopting international ACR-INDEX medical image code.