Subject Lifecycle Explorer
The eight-state participant journey with its gates and final states: screening, enrollment, randomization, and the ways a participant can exit.
server/src/modules/study/subjects/domain/subject-lifecycle.tsA participant moves through eight states with two gates: consent is recorded before screening begins, and the investigator confirms eligibility before enrollment. Five states are final. Every final state keeps all the data captured, and a reason is required to enter four of them.
Consented and being assessed against the inclusion and exclusion criteria. A participant cannot be recorded without a consent date and an ICF version. Eligibility is pending, eligible or ineligible, and only the investigator decides it; recording an ineligible determination screen-fails the participant in the same act.
The investigator found the participant ineligible, with a coded reason. What was captured at screening is kept.
Terminal — no transitions out.
Eligible and enrolled; the visit schedule is generated from the baseline date. In a randomized study this is the state before randomization, where the arm allocated elsewhere is typed in.
Enrolled but never randomized (randomized studies only), with a reason.
Terminal — no transitions out.
On study and being followed.
Finished the study. Completion lists any forms still unsigned and needs an acknowledgement. Data can no longer be entered; a value is corrected only by answering a query.
Terminal — no transitions out.
Left the study by choice or by the investigator's decision, with a coded reason and a record of whether a safety follow-up is owed. The principal investigator makes this move.
Terminal — no transitions out.
The site can no longer reach the participant. An exit of its own, not a withdrawal: it needs a reason, what was tried and when, and a date.
Terminal — no transitions out.