
Designing RC training programs: what new regulatory staff must learn, in what order, and how to verify competency
Replace ad hoc shadowing with a phased curriculum sequenced by criticality and complexity, anchored in ICH E6(R3) Annex 1 qualification requirements.
Designing RC training programs: what new regulatory staff must learn, in what order, and how to verify competency
Most site-level regulatory training is, in my candid view, the silent failure mode of clinical research operations. A new regulatory coordinator arrives on Monday. The departing one has two weeks left. They sit together. The departing coordinator opens whatever submission happens to be due that week and walks through it. The new one takes notes. After two weeks, the departing coordinator leaves, and the new one figures out everything else by encountering it.