Advice BAREC patient facing documents

Based on the Question & Answers document provided from the Clinical Trials Regulation (EU) No
536/2014, not all patient facing documents need to be submitted for EC review.

Patient facing documents are defined as documents, other than recruitment material or subject
information sheets, presented to clinical trial participants during the conduct of the clinical trial.

Patient facing documents that are linked to the endpoints of the clinical trial shall be provided
together with the protocol in part I of the clinical trial application, in the same language as the
submitted Informed Consent Forms (ICFs) . These documents will be assessed during the part I
assessment.

Other patient facing documents, other than documents that are linked to the endpoints of the
clinical trial, should be submitted in Part II.

Here’s a list of patient-facing documents that sponsors are not required to submit (no EC review
necessary):

• Insurance certificate in language of the patient
• Patient cards, trial identification cards
• Instructions on how to use a tablet or phone to complete e.g. e-questionnaires
• Digital vouchers/cards used to reimburse participants