Master Ethical Trial Conduct, Documentation, and Audit-Ready Compliance!
4.9/5 star reviews
Thousands of happy customers worldwide
Anxious about unexpected audits and potential findings.
Unclear on how to obtain and document informed consent correctly.
Struggling to maintain data integrity across multiple systems.
Confusion regarding which essential documents must be filed and when.
Limited career growth due to lack of recognized GCP certification.
Follow our audit-ready documentation workflow.
Implement gold-standard informed-consent procedures.
Apply ALCOA+ principles using provided data-entry checklists.
Use our curated templates to organize your Trial Master File.
Showcase an industry-recognized certificate on your CV and LinkedIn.
Explore the history, scope, and core principles of ICH E6(R2) and understand why GCP matters.
Define the legal and ethical responsibilities of investigators, sponsors, and monitors.
Learn how to protect human subjects through informed consent, safety oversight, and IRB/IEC communication.
Create, manage, and maintain essential documents such as protocols, Investigator’s Brochure, and the Trial Master File.
Implement risk-based monitoring, handle protocol deviations, and ensure continuous quality during study conduct.
Detect, document, and report adverse events and serious adverse events in compliance with global regulations.
" After taking this course, our site passed an FDA inspection with zero findings. Dr. Carter’s practical tips were invaluable! "
" This certification helped me land a Senior CRA position at a global CRO within three months. "
" Finally, a GCP course that makes complex regulations easy to understand. The downloadable SOP templates saved me weeks of work. "
Foundations of ICH GCP
Explore the history, scope, and core principles of ICH E6(R2) and understand why GCP matters.
Roles & Responsibilities
Define the legal and ethical responsibilities of investigators, sponsors, and monitors.
Ethics & Participant Safety
Learn how to protect human subjects through informed consent, safety oversight, and IRB/IEC communication.
Essential Trial Documentation
Create, manage, and maintain essential documents such as protocols, Investigator’s Brochure, and the Trial Master File.
Quality Management & Monitoring
Implement risk-based monitoring, handle protocol deviations, and ensure continuous quality during study conduct.
Safety Reporting
Detect, document, and report adverse events and serious adverse events in compliance with global regulations.
Data Integrity & Confidentiality
Maintain ALCOA+ data-integrity principles across paper and electronic systems and safeguard confidentiality.
Audit & Inspection Preparedness
Prepare for sponsor, FDA, and EMA inspections with confidence using our audit-readiness framework.
4.9/5 star reviews
Gain the knowledge, confidence, and credential you need to manage and monitor clinical trials ethically and efficiently.
Instant access to over 50 bite-sized HD video lessons (7+ hours).
Downloadable checklists, SOP templates, and regulatory reference guides.
Entry to a private GCP study group for peer discussion and Q&A.
Lifetime updates reflecting new ICH revisions and regional regulations.
Today Just
"Best purchase ever!"
" This certification helped me land a Senior CRA position at a global CRO within three months. "
Former FDA GCP inspector with 300+ successful site audits completed.
Served as lead trainer for multiple top-10 pharmaceutical companies.
Mentored more than 5,000 research professionals worldwide.
Published author in The Journal of Clinical Research Best Practices.
Keynote speaker at DIA and ACRP annual conferences.
Developed SOP libraries adopted by 60 research organizations.
We want you to find value in our trainings! We offer full refunds within 30 days. With all of our valuable video training, we are confident you WILL love it!
Yes. The curriculum aligns with ICH E6(R2) guidance and meets the GCP training expectations of major sponsors, CROs, and regulatory bodies.
No. We start with foundational concepts while still providing advanced insights, making the program suitable for beginners and seasoned professionals alike.
You receive lifetime access, including all future updates, so you can revisit any lesson whenever regulations change.
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