Data Management and Programming



课程长度:50 Hours





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