ICH-GCP Essentials
Good Clinical Practice as it actually shows up in daily decisions at a site and in a study team.
- Level
- Foundation
- Length
- 6 hours
- Lessons
- 15
- Format
- Self-paced
What you will be able to do
- Apply GCP principles to everyday site decisions
- Recognise a protocol deviation and handle it
- Explain participant protection in practical terms
- Read an inspection finding and see the cause
Course content
5 sections · 15 lessons · 6h total
Requirements
- No clinical research experience required
- Comfortable reading professional English documents
Who this is for
- Career transitioners moving into clinical research
- New coordinators, assistants and study staff
- Anyone who needs the vocabulary a first role assumes
Description
Good Clinical Practice as it actually shows up in daily decisions at a site and in a study team.
Written for people new to the topic, with nothing assumed. You work through 5 sections built around the tasks the role actually asks for, each with a short worked example and a checkpoint so you can tell whether the material has landed.
This sits in Foundations: Everything a first clinical research role assumes you know. When you are ready to show the capability rather than describe it, the next step is Protocol interpretation casebook in Competency Labs by TRUVAN.
Where it leads
Protocol interpretation casebook in Competency Labs by TRUVAN. Completing a course builds capability. It does not by itself create reviewed evidence: demonstrated work in Competency Labs by TRUVAN does.
Common questions
- Is this course assessed?
- No. Checkpoints are for your own confidence. Assessed, reviewed work happens in Competency Labs by TRUVAN casebooks.
- Does finishing this course create reviewed evidence?
- No. Courses build capability. Reviewed evidence comes from demonstrated work that is scored and reviewed in Competency Labs by TRUVAN.
- Can I buy this on its own?
- Yes. It is available as a single course, and it is also included in the TRUVAN Academy subscription alongside every other course and Labs access.
- How long do I have to complete it?
- It is self-paced with no deadline. Most people spread the material over two to three weeks alongside work.
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Source Documentation and ALCOA+
Documentation that survives monitoring, audit and inspection, written the way reviewers read it.
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