A modern, exciting online, on-demand course covering the Good Clinical Practice (GCP) requirements of both sponsors and the investigator site

 Based on the latest ICH GCP Guidelines E6(R3).

Needs no prior knowledge of GCP.

Ideal as core basic training.

This course aims to provide training on the key requirements of GCP relating to sponsors and investigators.

A great course to provide basic GCP knowledge to sponsors, investigators, service providers, ethics committees and regulators.

Can be used to refresh and update GCP knowledge.

Takes around 2.5 hours – stop and restart at any time.

Consists of 11 sections covering the following content.

• GCP Basics
• Risk Assessment, critical to quality factors, quality by design
• Trial site selection & suitability
• The trial protocol
• Requirements for ethics and informed consent
• Safety monitoring and reporting
• Investigational Product management
• Data quality and handling, including the use of computerised systems
• Trial monitoring & oversight
• Requirements for service providers
• Essential Records

Section quizzes to test and re-inforce knowledge prior to a final test.

Narrated, or read-only options.

Personalised with first name, interactions to aid learning.

Additional resources form part of the course including ICH E6(R3) and E8(R1) guidelines, Declaration of Helsinki 2024 and more.

Pass the final test (80% or more*) to be awarded certification.  *Opportunity to repeat incorrectly answered questions in the event of a test score lower than 80%.

 Available as fully serviced training (registration, activity monitoring, progress reporting, certification, helpline) or run it under licence on your own learning management system.

This course has been awarded 6 CPD points from the Royal Colleges of Physicians of the United Kingdom.