Definition

The measurement of whether risk minimization measures achieve their intended goals of reducing risk occurrence or severity.

Example

Effectiveness evaluation shows: 85% of prescribers report using the HCP guide, pregnancy rate in treated women is 0.1% (target <0.5%), and hepatotoxicity monitoring compliance is 90%.

Regulatory source

EU GVP Module XVI

Common mistakes

Measuring only distribution of materials rather than behavioral change and actual risk reduction.

Inspector question

How do you measure RMM effectiveness? What metrics indicate success or need for improvement?

Related terms