17 januari: Risk-based Quality Management

Question 1

Why is it essential to conduct proper risk-based quality management before the start of the CT? (think of human nature)

Answer 1

We start out with (too) many insurances, we end with too much risk-taking because we need to get results. That is why we start with critical processes & data identification

Question 2

Name and describe the 7 required steps for quality management.

Answer 2

1) Critical process and data identification (e.g. consent procedures, safety recording, primary endpoints)
2) Risk identification
3) Risk evaluation (against controls)
4) Risk control (at this point, you have a list and you can decide which risks you want to eliminate and which you accept, quality tolerance limits)
5) Risk communication
6) Risk review
7) Risk reporting (>CSR)

Question 3

What are the four types of risk identification?

Answer 3

• Risks to CT processes (e.g. how to keep double-blind)
• Risks to critical data (e.g. measurement)
• System level (we denken op het lichaam, dus wat voor invloed heeft de medicatie?)
• Trial level (e.g.?)

Question 4

What does risk evaluation consist of? (think of the surface/quadrant raster he drew on the board)

Answer 4

Against control..
… chance of occurrence
… detectability
… impact (on subjects & trial results)
… remedial actions (how are you going to improve when something fails/does not go according to plan?)

Question 5

What does the phrase “With great power comes great responsibility” refer to? (tessa vindt hem niet okee)

Answer 5

To the centralization of monitoring, incorporated into the R2 addenum.

Question 6

What should be included in the CSR? (3)

Answer 6

• Quality management approach
• Important deviations
• Remedial actions