ICF – Trial at a glance

On 3/9/2020, the general assembly of BAREC agrees on the following statement regarding the section “trial at a glance” of the ICF template for interventional clinical trials with IMP on adult patients:

BAREC advices its members to check thoroughly each informed consent form (ICF) and especially the part “Trial at a glance” which must meet all requirements as indicated on the “Model ICF for interventional clinical trials with IMP on adult patients” available on the website of the Clinical Trial College. Not meeting these requirements should result in a negative opinion as far as the research ethics committee (REC) is concerned.