Good Clinical Practice Course
4/5
This Good Clinical Practice course equips learners with essential knowledge to conduct safe and compliant clinical trials. It covers ICH E6(R2) principles, ethics committee roles, informed consent, protocol design, site setup, documentation management, monitoring, audits, CAPA processes, safety surveillance, SAE reporting, and risk management, ensuring high-quality trials from start to finish while protecting participants and meeting global standards.
4.0 in the evaluation
from 4 to 360h flexible workload
valid certificate in your country
What will I learn?
Gain a practical overview of ICH E6(R2) Good Clinical Practice principles, ethics committee and informed consent requirements, protocol design, and site initiation processes. Master documentation management, monitoring, audits, CAPA implementation, safety surveillance, serious adverse event reporting, and risk management to ensure compliant, high-quality clinical trials throughout all phases from initiation to closure.
Elevify advantages
Develop skills
- Apply ICH-GCP and local regulations to conduct compliant, audit-ready clinical trials efficiently.
- Design ethical informed consent processes with clear ICFs, fair compensation, and robust safeguards.
- Establish high-quality clinical trial sites using SOPs, delegation logs, and accurate source documentation.
- Develop strong safety systems including SAE workflows, reporting timelines, and risk mitigation strategies.
- Lead effective monitoring and CAPA through remote visits, root cause analysis, and SOP improvements.
Suggested summary
Before starting, you can change the chapters and workload. Choose which chapter to start with. Add or remove chapters. Increase or decrease the course workload.What our students say
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