Originally aired on April 16 | 6:00 PM CEST
This expert-led session explores the evolving role of Case Report Forms (CRFs) and study databases under ICH GCP E6(R3). As critical trial data now extends beyond traditional CRFs, the webinar breaks down what this shift means for data quality, oversight, and compliance.
Key Topics Covered:
The expansion of critical data sources — including wearables, eCOA, and real-world health records
Embedding risk-based principles into planning, monitoring, and data collection
Building intentional data governance across the trial lifecycle — from capture to audit trails
Speaker: Nechama Katan, a leading expert in RBQM and data strategy, brings 8+ years of experience implementing RBQM at a global pharma company and a strong academic background in mathematics and statistics (NYU, Columbia).
Who It’s For:
Clinical operations, data management, quality, and regulatory professionals transitioning to E6(R3) — especially those looking for actionable guidance to update their systems and SOPs.
+ Continue Learning:
Explore our full ICH GCP E6(R3) Online Certification Course — with interactive content, case studies, and a downloadable E6(R2) vs R3 comparison tool:
https://theqarp.com/e6r3
This expert-led session explores the evolving role of Case Report Forms (CRFs) and study databases under ICH GCP E6(R3). As critical trial data now extends beyond traditional CRFs, the webinar breaks down what this shift means for data quality, oversight, and compliance.
Key Topics Covered:
The expansion of critical data sources — including wearables, eCOA, and real-world health records
Embedding risk-based principles into planning, monitoring, and data collection
Building intentional data governance across the trial lifecycle — from capture to audit trails
Speaker: Nechama Katan, a leading expert in RBQM and data strategy, brings 8+ years of experience implementing RBQM at a global pharma company and a strong academic background in mathematics and statistics (NYU, Columbia).
Who It’s For:
Clinical operations, data management, quality, and regulatory professionals transitioning to E6(R3) — especially those looking for actionable guidance to update their systems and SOPs.
+ Continue Learning:
Explore our full ICH GCP E6(R3) Online Certification Course — with interactive content, case studies, and a downloadable E6(R2) vs R3 comparison tool:
https://theqarp.com/e6r3
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