when a subject is screened a clinical trial
In all clinical trials, the typical process starts with a screening period. The screening period starts with the signing of the informed consent. During the screening period, inclusion/exclusion criteria for the study participation will be checked / tested. Subjects who meet all inclusion criteria and do not meet any exclusion criterion will be eligible to be randomized (in randomized trial) or to be dosed (in non-randomized trial).
Clinical Trial. 1  See Common Rule definition of research at 45 CFR 46.102(d). 2  See Common Rule definition of human subject at 45 CFR 46.102(f).