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.
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Fundamentals of GCP
- Product Code: Fundamentals of GCP
- Availability: In Stock
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£100.00