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 is not acceptable except in some very specific circumstances whereby the sponsor motivates why it is not possible to meet the requirements.

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UPDATE :

At the Symposium of BAREC on December 9, 2023, an updated decision was reached regarding the ‘trial at a glance’ section in the ICFs. BAREC agrees that a ‘trial at a glance’ section is deemed necessary for all ICFs related to adult participants, regardless of the study type and regardless of whether it concerns patients or healthy volunteers.

It is crucial for a participant, who is often not acquainted with the design of studies and the complex terminology related to legal and regulatory aspects, to comprehend the implications of their participation. On the other side, this provides professionals with the advantage of quickly gaining insight into the study.