Competency assessment: measuring regulatory proficiency beyond checkbox training completion
Distinguish demonstrated competency from completed training, design performance-based assessments, and diagnose whether errors signal training failure, assessment failure, or performance management.
Competency assessment: measuring regulatory proficiency beyond checkbox training completion
Here is a question I have asked sites for nearly two decades, and the answers still trouble me. When you certify that a coordinator is "qualified" to prepare an IRB submission, what evidence supports that claim? In nine cases out of ten, the answer is some variation of the same sentence: "She completed the training." A learning management system somewhere shows a green check, a date, perhaps a quiz score of 85 percent. The file is closed. The matter is settled.
Except, of course, it is not. Completion is a record of attendance. Competence is a record of performance. These are not the same thing, and ICH E6(R3) Annex 1 does not pretend they are. Section 2.1.1 defines a qualified person as someone whose training, education, and experience together produce the demonstrated ability to perform the task. The operative word is demonstrated. Section 2.3.2 reinforces it by requiring personnel to be "appropriately qualified" for their assigned activities — an outcome, not a transcript. And Section 4.3.2 obligates investigators to assess the appropriateness of the training their staff received, which is impossible if the only evidence is a completion timestamp.
This lesson teaches you the difference between confirming that someone sat through a module and confirming that someone can do the work. It is, in my view, the single most underappreciated competency in regulatory operations leadership.
What you will learn
By the end of this lesson, you will be able to: