The CT College Board clarifies the role of the Ethics Committees (ECs) in evaluating clinical trial safety reports submitted under the European CTR.
This document is an example of an information leaflet which could be provided to participants of trials ongoing at 25th May 2018.
This document contains an example of the chapter “The trial at a glance” of the Model ICF for interventional clinical trials with IMP on adult patients.
FCPR Designating a confidant
FCPR Designating a representative