Following in
the footsteps of E6(R3) Principles and Annex 1, the final version of Annex 2
was adopted at Step 4 of the ICH process on 3 June 2026. It is now an integral
part of the E6(R3) guideline.
Whilst ICH
E6(R3) Principles and Annex 1 provide globally relevant guidance for the
conduct of interventional clinical trials, Annex 2 provides additional guidance
for interventional trials that incorporate decentralised elements, pragmatic
elements and real-world data (RWD).
This course summarises the guidance provided in E6(R3) Annex 2.
At the end
of the course, you will be aware of the additional GCP considerations for
trials involving decentralised elements, pragmatic elements, and real-world
data.
The personalised course lasts around 40 minutes, broken down into small sections.
You are able
to choose between a narrated or click through and read options.
The course
is laced with interactions to maintain attention.
It also features ten questions, some within the course and some at the end, which collectively allow you to assess your knowledge.
Sections in
the course include:
- Protocol and conduct
- Ethics
- Consent
- Investigational Product
- Oversight
- Safety
- Privacy
- RWD Access and Use
- Data Considerations
- Summary & further
questions
What are the benefits of this sponsor training?
• Online, on demand. Do it anywhere! All that is needed is a strong continuous internet signal
• Globally log in at any time 24/7, 365 days a year
• Delivery by html 5 allows PC, laptop, iPad, iPhone and android mobile devices to be used
• Tracking of user activity, progress reporting by user and group
• Certification for satisfactory completion
• The training is personalized using the participant’s first name
• The training is challenging and long enough to be a true training and evaluation option
• Costs depend on the number of participants with excellent packages for multiple users
• Fix costs with a 2-year agreement or longer
• Help in the event of problems
• Valuable e-resources in the course
For details of packages for training larger groups contact us at info@brookwood-global.com
ICH GCP E6(R3) Annex 2
- Product Code: ICH GCP E6(R3) Annex 2
- Availability: In Stock
-
£100.00
Available Options
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