Category:
Clinical Research |
Duration: 8 Weeks / 140 Hours |
Medidata RAVE EDC ( Electronic Data Capture)
Medidata RAVE EDC is the industry’s leading platform for capturing, managing, and reporting clinical trial data. It supports global studies across multiple therapeutic areas by streamlining eCRF design, data entry, query management, and integration with CTMS, eTMF, and Safety systems.
The RAVE EDC program prepares learners to understand, configure, and apply EDC functionalities in clinical trial operations. It blends regulatory data management foundations with hands-on RAVE workflows, enabling professionals to transition into data-focused roles in clinical research.
SIP – Self-Paced Online with Support
- Course Duration: 8 weeks (140 hours)
- Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and system-based tasks.
By completing this program, learners will:
- Understand the role of EDC in clinical data management.
- Learn to design, build, and validate eCRFs in RAVE.
- Manage subject enrollment, visit data, and eCRF completion.
- Perform data entry, discrepancy management, and query resolution.
- Apply edit checks, validation rules, and data cleaning processes.
- Ensure compliance with CDISC, ICH-GCP, FDA 21 CFR Part 11, and GDPR.
- Generate standard and custom reports for sponsors and CROs.
- Integrate RAVE EDC with CTMS, eTMF, and Safety systems.
- Support audit readiness with complete data trails and QC.
- Clinical Data Managers (CDMs) and Data Coordinators
- Clinical Research Associates (CRAs) learning site-level EDC tasks
- Clinical Trial Assistants (CTAs) supporting data workflows
- Biostatistics / SAS Programmers requiring data extraction knowledge
- Career changers entering Clinical Data Management roles
- Gain hands-on expertise in RAVE EDC workflows.
- Learn to design eCRFs, manage queries, and perform discrepancy resolution.
- Build readiness for CDM, CRA, and CTA roles in pharma and CROs.
- Enhance employability in data management and clinical systems support.
- Be prepared for regulatory inspections and database lock procedures.
.
- Clinical Data Manager (CDM)
- Clinical Trial Data Analyst
- RAVE EDC Specialist
- Clinical Research Associate (CRA)
- Data Quality Coordinator
- Statistical Programmer (with EDC exposure)
Modules | |
1. Introduction to EDC and RAVE platform overview 2. Study and protocol setup in RAVE 3. eCRF design, build, and edit checks 4. Subject enrollment and visit management 5. Data entry, discrepancy, and query resolution 6. Data validation, cleaning, and coding standards (CDISC, MedDRA, WHO-DD) 7. Role-based access and security compliance (21 CFR Part 11, GDPR) 8. Data extraction and reporting functionalities 9. Integration with CTMS, eTMF, and Safety databases 10. Database lock, archival, and inspection readiness |
For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.