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Principles of ICH E6(R3) Good Clinical Practice
Course Summary
The third revision of ICH GCP has reorganised and expanded the presentation of GCP principles. The principles themselves are now augmented by statements of the key expectations for clinical research conduct that arise from them. In this course, we present the principles and their consequent key expectations in full.
Purchasing Information
When you have completed your course order, Zenosis will finalise the setup of your course materials and contact you on the email address that you provide in your order. You can expect this process to be completed within one business day (using the UK business calendar) of completing your payment.
It is therefore essential that you use your real email address for your order, or indicate in the purchase notes the email address to be used for the course set-up, and check that any messages from Zenosis or grapl are not lost in your junk or spam folder.
You will have access to the course module(s)โfor a period of 180 days after your purchase is complete.
Detailed Course Information
Learning Objectives
โข Identify the 11 principles of GCP set out in ICH E6(R3)
โข Outline the key expectations for clinical research conduct that arise from these principles
Who will benefit from this course
Clinical development and regulatory affairs staff of medicinal products companies and service providers such as contract research organisations; healthcare professionals participating in clinical research
Module Outline
In this session, we present the principles and their consequent key expectations in full.
Roles
Research, Regulatory, Compliance, Other
CPD Points
No
Region
Level
Introductory/Intermediate
Course Study Time
20 minutes
USA, Europe, Other