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 班級規模及環境--熱線:4008699035 手機:15921673576( 微信同號) |
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每期人數限3到5人。 |
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上課時間和地點 |
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上課地點：【上海】：同濟大學(滬西)/新城金郡商務樓(11號線白銀路站) 【深圳分部】：電影大廈(地鐵一號線大劇院站)/深圳大學成教院 【北京分部】：北京中山學院/福鑫大樓 【南京分部】：金港大廈(和燕路) 【武漢分部】：佳源大廈（高新二路） 【成都分部】：領館區1號（中和大道） 【沈陽分部】：沈陽理工大學/六宅臻品 【鄭州分部】：鄭州大學/錦華大廈 【石家莊分部】：河北科技大學/瑞景大廈 【廣州分部】：廣糧大廈 【西安分部】：協同大廈
最近開課時間(周末班/連續班/晚班）：2020年3月16日 |
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實驗設備 |
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☆資深工程師授課
☆注重質量
☆邊講邊練
☆合格學員免費推薦工作
★實驗設備請點擊這兒查看★ |
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質量保障 |
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1、培訓過程中，如有部分內容理解不透或消化不好，可免費在以后培訓班中重聽；
2、培訓結束后,授課老師留給學員聯系方式,保障培訓效果,免費提供課后技術支持。
3、培訓合格學員可享受免費推薦就業機會。 |
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課程大綱 |
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課程介紹：
本課程旨在為學員提供臨床試驗和其他項目中使用的臨床數據，從而為臨床數據管理（CDM）的學歷和專業資格管理的工作知識。課程發展涉及與業界廣泛咨詢。該課程適合衛生信息管理，數據管理和其他衛生專業人員使用，或與策劃，臨床資料和其他健康數據庫的工作。該方案提供了那些參加了刺激和愉快的機會發展作為個人和作為專業人士，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驗獲得的知識。
課程對象：
博士，碩士，內外全科醫學士，BDS，BHMS，BAMS，燒傷，BPT，B制藥，研究生/研究生學歷，生命科學，藥理學，藥劑學，醫學檢驗，護理，生物化學，微生物學，生物技術和制藥公司工作的所有專業人士，CRO和醫院。
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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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???????
Troubleshooting Java Applications
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Classpath Errors
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Class Loaders
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Common Java Errors
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Troubleshooting Servers
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Native Libraries
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Threading Architecture
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Work Managers
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Deadlocks
? ? ? ? ? ? ? ?
Overload Protection
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Deployment Problems
???????
Troubleshooting JDBC
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Data Source Management
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Diagnostics
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Debug Flags
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Connectivity Problems
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Connection Leaks
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Database Availability
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Troubleshooting JMS
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Management
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MBean Hierarchy
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Message Logging
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Diagnostics
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Debug Flags
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Overload Protection
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Lost Messages
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Duplicate Messages
???????
Troubleshooting Security
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SSL Internals
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Keystore Management
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Debug Flags
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Common SSL Problems
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Certificate Validation
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Embedded LDAP
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Security Audit
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Common LDAP Problems
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Troubleshooting Node Manager
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Internals
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Security
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Common Issues
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Troubleshooting Clusters
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Plug-in Configuration
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OHS Overview
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Plug-in Connectivity
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Plug-in Diagnostics
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Unicast Communication
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Replication Debug Flags
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Typical Replication Issues
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