Good Clinical Practice Course
This Good Clinical Practice course equips you to conduct safe and compliant clinical trials. Gain expertise in ICH E6(R2) principles, ethics committee approvals, informed consent processes, protocol development, site setup, documentation management, safety surveillance, SAE reporting, monitoring, audits, and CAPA. Protect participants and adhere to global regulatory standards from trial initiation to closure, ensuring high-quality outcomes.

flexible workload of 4 to 360h
valid certificate in your country
What will I learn?
Explore ICH E6(R2) principles, ethics committee requirements, informed consent, protocol design, and site initiation in this practical Good Clinical Practice course. Master documentation management, monitoring, audits, CAPA, safety surveillance, SAE reporting, and risk management to deliver compliant, high-quality clinical trials throughout all phases.
Elevify advantages
Develop skills
- Apply ICH-GCP and local regulations to conduct compliant, audit-ready clinical trials efficiently.
- Design ethical informed consent forms with clear language, fair compensation, and robust participant safeguards.
- Establish high-quality clinical trial sites using SOPs, delegation logs, and accurate source documentation.
- Develop strong safety systems including SAE reporting workflows, timelines, and risk mitigation strategies.
- Manage monitoring activities and CAPA processes with remote visits, root cause analysis, and SOP improvements.
Suggested summary
Before starting, you can change the chapters and the 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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