en
excluded_subject_role
recruited participant that could not or would not participate in the trial (source: RCT Schema)
recruited participant that did not satisfy one or more eligibility criteria (source: RCT Schema)
not_eligible_subject_role
medical_monitor
randomized_subject_role
eligible participant that was assigned to one of the intervention arms according to the randomization scheme (source: RCt Schema)
potential participant that agreed to undergo screening for the trial
recruited_subject_role
clinical_research_associate
Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors
the progress of investigator sites participating in a clinical study (Source CDISC Glossary).
crossover_subject_role
participant who 'crossed over' to another arm's intervention off protocol, i.e., assigned to one arm but received treatment of another arm (souce: RCT Schema)
screened_subject_role
recruited participant that underwent eligibility evaluation (source: RCT Schema)
eligible participant that agreed to participate in the trial and signed the informed consent (source: RCT Schema)
enrolled_subject_role
clinical_research_coordinator
study coordinator
Person who handles most of the administrative responsibilities of a clinical trial on behalf of a site investigator, acts as liaison between investigative site and sponsor, and reviews all data and records before a monitor’s visit (Source CDISC Glossary).
randomized participant whose data were collected and analyzed to reach conclusions about the experimental treatment (source: RCT Schema)
analyzed_subject_role
screened participant that satisfied all eligibility criteria for the trial (source: RCT Schema)
eligible_subject_role
study_arm_subject_role
randomized participant that was assigned to a treatment arm of the trial (source: RCT Schema)