Electronic Data Capture Systems
( 24 Modules )

Module #1
Introduction to Electronic Data Capture Systems
Overview of EDC systems, benefits, and importance in clinical trials

Module #2
History and Evolution of EDC Systems
From paper-based to digital data capture, understanding the evolution of EDC systems

Module #3
Key Components of an EDC System
Understanding the core components, including data capture, data management, and reporting

Module #4
Types of EDC Systems
Cloud-based, on-premise, and hybrid EDC systems:pros and cons

Module #5
EDC System Selection and Implementation
Best practices for selecting and implementing an EDC system

Module #6
Data Standards and Interoperability
Understanding CDISC, HL7, and other data standards for EDC systems

Module #7
Data Validation and Quality Control
Ensuring data quality and integrity in EDC systems

Module #8
User Roles and Permissions
Understanding user roles, permissions, and access control in EDC systems

Module #9
Data Capture Methods
Overview of data capture methods, including eCRFs, surveys, and mobile apps

Module #10
Electronic Case Report Forms (eCRFs)
Designing and building eCRFs, including data validation and formatting

Module #11
Data Migration and Integration
Migrating data from legacy systems and integrating with other systems

Module #12
Data Analytics and Reporting
Generating reports and analyzing data in EDC systems

Module #13
Compliance and Regulatory Aspects
Meeting regulatory requirements, including 21 CFR Part 11 and GDPR

Module #14
Security and Data Protection
Ensuring data security and protection in EDC systems

Module #15
Change Management and Version Control
Managing changes to EDC systems and version control best practices

Module #16
Training and User Adoption
Developing training programs and strategies for user adoption

Module #17
EDC System Validation and Testing
Validating and testing EDC systems to ensure data quality and integrity

Module #18
Best Practices for EDC System Deployment
Lessons learned and best practices for deploying EDC systems

Module #19
EDC System Maintenance and Support
Ongoing maintenance and support requirements for EDC systems

Module #20
EDC System Integration with Other Clinical Trial Systems
Integrating EDC systems with CTMS, eTMF, and other clinical trial systems

Module #21
Trends and Future Directions in EDC Systems
Emerging trends and technologies in EDC systems

Module #22
Case Studies in EDC System Implementation
Real-world case studies of EDC system implementation

Module #23
EDC System Cost-Benefit Analysis
Conducting cost-benefit analysis for EDC system implementation

Module #24
Course Wrap-Up & Conclusion
Planning next steps in Electronic Data Capture Systems career

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Electronic Data Capture Systems ( 24 Modules )

Electronic Data Capture Systems
( 24 Modules )