Core Certificate
Go Beyond a Slide-Only GCP Certificate
Understand the principles of ICH-GCP E6(R3) and apply them to realistic operational decisions involving participant protection, trial quality, data governance and oversight.
You will practise
- Identifying critical-to-quality factors
- Using risk-proportionate trial processes
- Recognising sponsor and investigator oversight duties
- Managing computerized systems and clinical data responsibly
- Supporting remote or decentralized activities
- Investigating root causes and planning CAPA
- Documenting decisions clearly and auditably
Course promise: E6(R3) applied to actual clinical operations — not simply a certificate of attendance.
Ethics, Safety and Data Courses
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