Substantial vs non-substantial amendment

Classify a protocol change in the EU

Role: Regulatory Affairs / Clinical Operations

Context: Your multi-country EU trial is ongoing. The sponsor wants to add a single extra blood draw at the Week 4 visit for exploratory biomarker analysis. The visit schedule and all other procedures are unchanged.

Task: Determine whether this is a substantial amendment and what must be done before sites can implement it.

Step 1 of 1

Substantial or not?

info

The change: one additional blood sample at Week 4 for exploratory research. No change to primary/secondary endpoints, no new risks highlighted in the protocol, no change to inclusion/exclusion criteria. Local ethics and competent authority requirements apply.

Is this a substantial amendment in the EU?