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研究生:黃俊喬
研究生(外文):Chun-Chiao Huang
論文名稱:以標準為基礎之電子化個案報告表設計系統研究
論文名稱(外文):The Study of Standard-based Electronic Case Report Form Design System
指導教授:劉德明劉德明引用關係
指導教授(外文):Der-Ming Liou
學位類別:碩士
校院名稱:國立陽明大學
系所名稱:生物醫學資訊研究所
學門:工程學門
學類:生醫工程學類
論文種類:學術論文
畢業學年度:97
語文別:中文
論文頁數:57
中文關鍵詞:電子資料擷取系統臨床試驗資料搜集CDISC (Clinical Data Interchange Standards Consortium)CDASH (Clinical Data Acquisition Standards Harmonization)電子個案報告表
外文關鍵詞:electronic data capture (EDC) systemclinical trial data collectionCDISC (Clinical Data Interchange Standards Consortium)CDASH (Clinical Data Acquisition Standards Harmonization)electronic case report form
相關次數:
  • 被引用被引用:2
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  • 下載下載:80
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  隨著電子病歷以及使用電子資料擷取系統的成長,病患照護資料的重用變得更為可能。然而,對於整合病人照護及臨床研究以促進臨床試驗的資料搜集這方面而言,仍然有著極大的挑戰。由於臨床資料管理系統和電子病歷系統間缺乏通透性,導致一個執行多個臨床試驗的醫院必需使用客製化的電子資料擷取系統或由研究者重覆輸入臨床資料。
  臨床試驗資料搜集的效率低落,除了會導致試驗進度的延遲、資料品質低落和增加成本外,甚至會因為未能發現潛在的危險而造成病人的傷害,資料的搜集對於臨床試驗有著極大的影響。為了提升通透性,本研究提出一個基於CDISC CDASH標準的電子個案報告表設計系統,希望能藉由提供系統內建的標準個案報告表,輔助臨床試驗個案報告表的設計,並且藉由使用標準標案報告表,降低電子資料擷取系統的客製化需求。
With the growth of electronic health records (EHR) and increasing use of electronic data capture (EDC) system, the reuse of patient care data is becoming possible. However, integrating patient care with clinical research to facilitate clinical trial data collection still remains a great challenge. Due to the lack of interoperability between EHR systems and clinical data management systems (CDMS), an investigational site conducting several clinical trials may have to either use customized EDC systems or manually re-enter clinical data by researchers for each clinical trial.
Inefficiencies in clinical trial data collection may cause delays and poor data quality, increase costs, and may even harm patients due to the inability to identify potential risks thus significantly impacting the clinical research. To support interoperability, this study implemented an electronic case report form (eCRF) design system based on CDISC Clinical Data Acquisition Standards Harmonization (CDASH). The objective of this system is to facilitate the design of standard-based electronic case report form and minimize the need of customization for EDC system by providing build-in standardized case report form template.
誌謝 i
中文摘要 ii
Abstract iii
Table of Contents iv
List of Figures vii
List of Tables ix
List of Abbreviations x
Chapter I Introduction 1
1.1 Background 1
1.2 Motivation 3
1.3 Case Report Form 4
1.4 Specific Aims 4
1.5 Scope of this Study 5
1.6 Organization of this Thesis 6
Chapter II Literature Review 7
2.1 The Evolution of Clinical Trial Data Collection 7
2.1.1 Paper-based Data Collection 7
2.1.2 Remote Data Entry for Data Collection 8
2.1.3 Direct Data Capture for Data Collection 10
2.2 Standards Related to Clinical Trial Data Collection 11
2.2.1 Study Data Tabulation Model (SDTM) Standard 12
2.2.2 Terminology 14
2.2.3 Clinical Data Acquisition Standards Harmonization (CDASH) Standard 15
Chapter III System Design 17
3.1 System Requirements 17
3.2 Software Architecture 18
3.2.1 Three-tier Architecture 19
3.2.2 Apache Wicket Framework for Presentation Tier 20
3.2.3 Hibernate Framework for Logic Tier 22
3.2.4 Spring Framework for Both Logic Tier and Data Tier 23
3.3 User Stories 23
3.4 System Structure 24
Chapter IV System Implementation 27
4.1 Development Environment 27
4.2 System Implementation 29
4.2.1 Web Module Structure Design 30
4.2.2 Integration of Spring Framework with Hibernate and C3p0 31
4.2.3 Configuration of Apache Wicket 36
4.2.4 Configuration of Log4j 39
4.2.5 Configuration of Apache Ant 40
4.3 Build-in CDASH Template Design 43
4.4 System Results 45
4.5 System Evaluation 52
Chapter V Discussions and Conclusions 53
5.1 Discussions 53
5.2 Conclusions 54
5.3 Future Works 54
Bibliography 56
Appendix Source Code 57
1. Marks L, Power E. Using technology to address recruitment issues in the clinical trial process. Trends Biotechnol. 2002 Mar;20(3):105-9.
2. N. DSJ. The Future Vision of Electronic Health Records as eSource for Clinical Research. The eClinical Forum and PhRMA EDC Task Group. 2006 March 3.
3. Kim D, Labkoff S, Holliday SH. Opportunities for electronic health record data to support business functions in the pharmaceutical industry--a case study from pfizer, inc. J Am Med Inform Assoc. 2008 Sep-Oct;15(5):581-4.
4. Dugas M, Lange M, Berdel WE, Muller-Tidow C. Workflow to improve patient recruitment for clinical trials within hospital information systems - a case-study. Trials. 2008;9:2.
5. CDISC web site. [cited 2009 Janurary 15]; Available from: http://www.cdisc.org/
6. FDA Critical Path Opportunities List. 2006 [cited; Available from: http://www.fda.gov/oc/initiatives/criticalpath/reports/opp_list.pdf
7. CenterWatch. [cited; Available from: http://www.centerwatch.com/
8. Liora Alschuler RK, Landen Bain. Improving Data Collection for Patient Care and Clinical Trials. [cited; Available from: http://sciencecareers.sciencemag.org/career_development/previous_issues/articles/2940/improving_data_collection_for_patient_care_and_clinical_trials
9. IHE IT Infrastructure Technical Framework Supplement –RFD supplement. [cited; Available from: http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Suppl_RFD_TI_2006_09_25.pdf
10. CDISC CDASH version 1.0. 2009 [cited; Available from: http://www.cdisc.org/standards/cdash/downloads/CDASH_STD-1_0_2008-10-01.pdf
11. Machine KWRTE. Applying Technology to Optimize Clinical Trials. Drug Information Journal. 1998;32:861-9.
12. Hyde AW. The Changing Face of Electronic Data Capture: From Remote Data Entry to Direct Data Capture. Drug Information Journal. 1998;32:1089-92.
13. EDC Adoption in Clinical Trials: A 2008 Analysis, report of CenterWatch survey. Bio-IT World. 2008 February 2008.
14. Kush R, Alschuler L, Ruggeri R, et al. Implementing Single Source: the STARBRITE proof-of-concept study. J Am Med Inform Assoc. 2007 Sep-Oct;14(5):662-73.
15. CDISC Terminology. [cited 2009 Janurary 15]; Available from: http://www.cdisc.org/standards/terminology/index.html
16. Apache Log4j. [cited; Available from: http://logging.apache.org/log4j/1.2/index.html
17. Apache Ant. [cited; Available from: http://ant.apache.org/
18. Apache Commons. [cited; Available from: http://commons.apache.org/
19. c3p0. [cited; Available from: http://sourceforge.net/projects/c3p0
20. Standardized Case Report Form (CRF) Work Group. [cited; Available from: https://cabig.nci.nih.gov/workspaces/CTMS/CTWG_Implementation/crf-standardization-sig/index_html
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