Signal Detection and Risk Management
Aggregate safety review, signal management and the documents that carry a product's risk position.
- Level
- Advanced
- Length
- 7 hours
- Lessons
- 12
- Format
- Self-paced
What you will be able to do
- Run an aggregate safety review
- Work a signal through to a decision
- Read a DSUR and PBRER
- Connect signals to risk minimisation
Course content
4 sections · 12 lessons · 7h total
Requirements
- A working understanding of ICH-GCP and study conduct
- Helpful, not required: exposure to adverse event handling
Who this is for
- Safety, pharmacovigilance and site staff handling events
- Coordinators responsible for reporting timelines
- Study teams accountable for participant safety
Description
Aggregate safety review, signal management and the documents that carry a product's risk position.
Written for experienced professionals who own the outcome. You work through 4 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 Safety and pharmacovigilance: Adverse events, reporting and signal work. When you are ready to show the capability rather than describe it, the next step is Safety and pharmacovigilance specialty track.
Where it leads
Safety and pharmacovigilance specialty track. 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.