Good Clinical Practice (Int)

This training solution is designed to meet all criteria, and regulatory requirements by international inspection organisations, such as FDA, MHRA, EMA and others and is valid for mutual recognition of Good Clinical Practice training among sponsors and clinical research organisations.

• Module 1 – Introduction
• Module 2 - History and Principles of ICH-GCP
• Module 3 – Informed Consent Process, Documentation
  
• Module 4 – Roles and Responsibilities according to ICH-GCP
  
• Module 5 –Adverse & Serious Adverse Events
  
• Module 6 – Essential documents
  
• Module 7 - Drug Accountability & Compliance
  
• Module 8 - Monitoring, Auditing & Inspection

This training is also available as a corporate solution, which allows professionals with administrative functions, such as R&D, Training, QA, Clinical Operation, HR Managers, to manage and monitor the whole learning process/curve:

• licences and access management
  
• performance statistics and outcomes
  
• certificate management
• reports

The GCP training is also offered in the form of face-to-face training, where experts from our International Network of Trainers come to you; additional content customisations are available upon request.