Clinical Research & GCP
Master ICH-GCP compliance, site management, and audit readiness
LEVELS
Training Levels
Choose the right level for your team
Foundation
LEVEL 1New staff, residents entering clinical research
- Introduction to drug development
- ICH-GCP principles
- Essential investigator responsibilities
Professional
LEVEL 2Experienced coordinators
- Subject recruitment strategies
- Informed consent workshops
- Safety reporting (AE/SAE)
- Source data verification
Mastery
LEVEL 3Study managers, CRU directors
- Quality management systems
- Handling misconduct/fraud
- Audit preparation
- Complex trial management
OUTCOMES
Learning Outcomes
Achieve full compliance with ICH-GCP E6(R2), SFDA, and international standards
Reduce query rates and protocol deviations through better site management
Learn to identify risks early and implement effective CAPA
Prepare your team to pass regulatory inspections and sponsor audits
Move from foundational knowledge to expert-level strategic leadership
AVAILABILITY
Training Formats
On-Site Training (KSA)
CERTIFICATE INCLUDED
Virtual Classroom
CERTIFICATE INCLUDED
Europe Immersion
CERTIFICATE INCLUDED
All participants receive an MFG Training certified completion certificate upon successful program completion.
Key Topics
Key Topics
- 1ICH-GCP Principles & Essential Investigator Responsibilities
- 2Informed Consent Workshops & Subject Recruitment Strategies
- 3Safety Reporting (AE/SAE) & Source Data Verification
- 4Quality Management Systems, Audit Preparation, & Handling Misconduct
Not Sure Where to Start?
Assess your team's experience levels and exact training needs with a customized consultation.
- Level Recommendations
- Customized Proposals
- Flexible Scheduling