International GCP Training

About this course

This is a professionally developed and beautifully designed online Good Clinical Practice training course with audio narration (free demo).

It has been accredited for Continuing Professional Development by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. The GCP training has been approved for a maximum of 6.5 CPD credits based upon 1 credit for each hour of learning.

It meets international requirements and standards set by regulatory bodies and provides official certificate of achievement. It is suitable for anyone carrying out, or involved in, clinical research and clinical trials and also for all individuals that need official certification in GCP.

The training is approved by big international pharma industry organizations and meets their requirements for mutual recognition of GCP training among trial sponsors.

Learning objectives

The training aims to help students understand:

• the specific roles and responsibilities of the key players in a clinical trial - e.g. investigators, sponsors, monitors, ethics committees and support staff;
• how to comply with documentation and report obligations, how to avoid GCP non-compliance and how to conduct a quality trial;
• the principles of data capture and data quality;
• the informed consent process and its key aspects;
• the structure and content of the study protocol and investigator`s brochure;
• the purpose and types of the essential documents;