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Compliance
ICH-GCP Clinical Research Essentials
Role-based GCP training for monitors, coordinators, and sites — aligned with ICH E6(R2) and sponsor audit expectations.
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6/1/2024
Overview
A global pharmaceutical sponsor needed consistent GCP literacy before a wave of multi-country trials.
The program:
- Maps content to study roles (CRA, CRC, PI)
- Uses investigator-site scenarios
- Includes audit-ready acknowledgements
The Challenge
GCP training was fragmented across vendors; auditors found inconsistent evidence of competency.
The Solution
A modular curriculum with role pathways, localized case law callouts, and a single LMS source of truth for completions.
Results
Unified completion reporting; sponsor QA noted fewer protocol deviations tied to training gaps in pilot sites.
Tools Used
Rise 360
Docebo
Adobe Acrobat
