This 6-hour interactive online GCP course, is designed to meet all criteria and regulatory requirements of international regulatory bodies - FDA, MHRA and EMA. Upon successful completion users are issued an individual GCP certificate recognised by sponsors and CROs worldwide. Preview your certificate here or start a free trial in the FREE DEMO section below.
The course is created by top industry experts and is appropriate for all current and future clinical research professionals.
Expert interpretation of GCP Regulations, including ICH GCP E6 (R2) addenda
Covering all the changes/amendments proposed in the EU Directive 2005/28/EC
Covering all the changes/amendments proposed in the Clinical Trial Regulation (CTR) (Regulation (EU) No 536/2014)
Interactive content, including video materials, visuals and case studies
Learn at your own pace
Flexible administrative options for corporate clients
Why is this training important?
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.
Full training content
Module 1 - Introduction
Module 2 - Key Changes brought about by ICH GCP E6 R2 Addendum
Module 5 - Roles and Responsibilities according to ICH-GCP
Module 6 - Adverse and Serious Adverse Events
Module 7 - Essential Documents
Module 8 - Drug Compliance and Accountability
Module 9 - Monitoring, Auditing and Inspections
Corporate Solutions and Certification
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
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.