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課程介紹：
本課程旨在為學(xué)員提供臨床試驗和其他項目中使用的臨床數(shù)據(jù)，從而為臨床數(shù)據(jù)管理（CDM）的學(xué)歷和專業(yè)資格管理的工作知識。課程發(fā)展涉及與業(yè)界廣泛咨詢。該課程適合衛(wèi)生信息管理，數(shù)據(jù)管理和其他衛(wèi)生專業(yè)人員使用，或與策劃，臨床資料和其他健康數(shù)據(jù)庫的工作。該方案提供了那些參加了刺激和愉快的機(jī)會發(fā)展作為個人和作為專業(yè)人士，增加了對技能的效率，效能，容量和能力，以及建筑和寶貴的工作經(jīng)驗獲得的知識。

課程對象：
博士，碩士，內(nèi)外全科醫(yī)學(xué)士，BDS，BHMS，BAMS，燒傷，BPT，B制藥，研究生/研究生學(xué)歷，生命科學(xué)，藥理學(xué)，藥劑學(xué)，醫(yī)學(xué)檢驗，護(hù)理，生物化學(xué)，微生物學(xué)，生物技術(shù)和制藥公司工作的所有專業(yè)人士，CRO和醫(yī)院。

課程大綱：

Week 1
???? Introduction to Biomedical Informatics: Clinical Trial concepts and definition
???? Clinical Trial process, design and protocol
???? Clinical data flow and management
???? Role of Clinical Trial Teams and key functions.
???? Clinical Data Management and clinical programming
???? Technology in clinical trials.
???? Case Study 1: Clinical Trial Study Case
Week 2
???? Introduction to Pharmaceutical business and drug discovery process.
???? Drug development process and introduction of phases
???? Clinical research & development overview in pharmaceutical industry
???? FDA regulation & guidelines & data standards
???? Good clinical practices.
???? Introduction to data Management and clinical programming.
???? Introduction to DBMS and Oracle Clinical.
???? Logging into Oracle Clinical and basic menu options.
Week 3
???? Brief introduction to OC architecture
???? Explanation of three tier structure
???? Explanation and brief discussion about relational databases.
???? Design and definition of a clinical study in OC
???? Use Oracle Clinical to set up studies
o??? How To Use Oracle Clinical “Study Design Module”? to Design Studies, Manage Study Level Project, Investigator and? Sites
o??? How To Use Oracle Clinical “Study Design Module” to Set Up Treatments, Timeline, Schedule and Perform Events.
o??? How To Use Oracle Clinical “Study Design Module”? to Create and Maintain Study
Week 4
???? Introduction to use of Global library objects.
???? Design and definition of DCM and DCI
???? Creation of character layouts and screens
???? Handover of sample CRF’s for DCM/DCI creation for class practice
???? Hands-On Case Study: Set Up a Study Environment and Design a Clinical Study
Week 5
???? Introduction to creation of CPE’s and Intervals
???? Role and importance of study sites and investigators
???? Creation of patient positions and association with study sites.
???? Creation of default OC views.
???? Introduction to RDC and graphic layouts.
Week 6
???? Review of DCM’s and Data entry
???? Introduction to the validation procedures
???? Explanation of inner workings of the validation procedures.
???? Differences in the functionality of online/offline procedures.
???? Explanation of the working of cursors in the validation procedures
???? Introduction to the derivation procedures.
???? Programming of Validation Procedures.
???? Correlation of QG’s
???? Use of CPE’s in Validations
???? Editing generated code for VP’s
???? User variables in programming of VP’s.
???? Use of custom code.
???? Programming techniques for derivation procedures.
Week 7
???? Review of VP/DP programming
???? Detailed discussion of OC extracts.
???? Use of key template and view template in view programming.
???? Changing the default sequence in view programming.
???? Customization of OC views.
???? Introduction to CDISC and SDTM.
???? Consideration in CDISC programming.
???? Current interpretation of SDTM 3.1.2 and its impact on clinical trials
Week 8
???? Clinical Data Management Processes??? ??? ??? ???
???? Case Report Form Design
???? General Data Flow
???? Tracking and Logging-in
???? Preparation of Data Entry
???? Use Oracle Clinical for Data Capture
???? Electronic Data Entry Technology
???? Data entry through RDC
???? Data Review and Validation/Queries
Week 9
???? A role of a Clinical Data Management in data verification
???? Identifying and developing data checks
???? Data Queries
???? Using Oracle Clinical to do Discrepancy Management
???? Data Clarification Forms and its generation using OC
???? Quality Process
???? Quality Assurance Audits
???? Clinical Study Report
???? Database Release Processes
???? Using Oracle Clinical to facilitate “Locking” of the study
???? Statistical Review considerations
Week 10
???? EDC and its advantage
???? Current Processes and Technology
???? Site Source Document verification and approval
???? Working with the sites on EDC
???? Explanation of other functionalities of RDC and their importance in Data management.
???? Use Oracle RDC to manage remote Clinical Data Capture

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