Blinding

Blinding reduces bias in how outcomes are reported and assessed. When the device itself makes blinding impossible, an observer-blind design, where the person assessing the primary endpoint does not know the assignment, is a common alternative.

procedure in which one or more parties to the clinical investigation (3.8) are kept unaware of the treatment assignment(s) Note 1 to entry: Single blinding usually refers to the subject(s) (3.50) being unaware of the treatment assignment(s). Double blinding usually refers to the subject(s), investigator(s) (3.30), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s). Note 2 to entry: A clinical investigation is termed “observer blind,” if at least the primary endpoint(s) (3.22) is/are assessed without knowledge of whether an investigational medical device (3.29) or comparator (3.12) has been used to treat a subject.

ISO 14155:2020, clause 3.5