WONJA
Course catalogue
Monitoring

Risk-Based Monitoring and Central Oversight

Critical data and processes, quality tolerance limits and how central signals change site visits.

Level
Advanced
Length
8 hours
Lessons
12
Format
Self-paced

What you will be able to do

  • Identify critical data and processes on a study
  • Set and use quality tolerance limits
  • Read central monitoring signals
  • Adjust site strategy from evidence

Course content

4 sections · 12 lessons · 8h total

Requirements

  • A working understanding of ICH-GCP and trial roles
  • Helpful, not required: exposure to site or CRO work

Who this is for

  • CRAs and monitors building or refreshing core practice
  • Site staff preparing for a monitoring move
  • Study teams who need to read monitoring output critically

Description

Critical data and processes, quality tolerance limits and how central signals change site visits.

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 Monitoring: Source verification, visits and site oversight. When you are ready to show the capability rather than describe it, the next step is Oversight and quality domain evidence.

Where it leads

Oversight and quality domain evidence. Completing a course builds capability. It does not by itself create Passport evidence: demonstrated work in Wonja Labs does.

See how Labs turns work into evidence

Common questions

Is this course assessed?
No. Checkpoints are for your own confidence. Assessed, reviewed work happens in Wonja Labs casebooks.
Does finishing this course create Passport evidence?
No. Courses build capability. Passport evidence comes from demonstrated work that is scored and reviewed in Wonja Labs.
Can I buy this on its own?
Yes. It is available as a single course, and it is also included in the Wonja 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.

More in Monitoring

The Monitoring Visit, Start to Report

Preparing, running and reporting a monitoring visit, including the judgement calls between findings.

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