At what point is a human subject considered to be “enrolled” in an applicable clinical trial?
“Enrolled” is defined in 42 CFR 11.10(a) as a human subject’s, or their legally authorized representative’s, agreement to participate in a clinical trial following completion of the informed consent process, as required in 21 CFR Part 50 and/or 45 CFR Part 46, as applicable. The regulation explains that, for the purposes of this part, potential subjects who are screened for the purpose of determining eligibility for a trial, but do not participate in the trial, are not consideredenrolled, unless otherwise specified by the protocol.
The Final Rule preamble (81 FR 65022) provides additional clarification of the “enroll or enrolled” definition in 42 CFR 11.10(a) by addressing two scenarios involving signing of the informed consent document. The first scenario involves the use of a separate informed consent document for screening. In this situation, there are two distinct informed consent documents: one for trial screening (for eligibility) and if eligible, one for trial participation. Under this first scenario, the signing of the second separate informed consent document for trial participation would mean the subject is enrolled in the clinical trial.
when there is only one informed consent document for both trial screening and trial participation, whether a human subject “participates” in a study, and is therefore considered “enrolled” under the definition in 42 CFR 11.10(a), is determined by the protocol. This determination may vary across clinical trial protocols. For example, assignment to a study arm may be considered the beginning of trial participation based on a particular study protocol.