What this is, and who it is for
A participant moves through a fixed set of statuses. Most moves are made for you (screening, enrollment). The moves a person makes on purpose, and that end a participant's time in the study, are completion, withdrawal, loss to follow-up, screen failure and randomization failure. Each asks for the facts the protocol needs and is recorded.
| You need | To |
|---|---|
subject.write | Activate an enrolled participant (site coordinator, principal investigator) |
subject.delete | Complete, withdraw, declare lost to follow-up (the principal investigator or an Organization Admin) |
subject.eligibility | Mark ineligible, which fails screening (principal investigator) |
Held by: Organization Admin, Principal Investigator (subject.delete).
Where to find it
The status badge at the top of a participant's page is a menu: Move subject to. It offers only the moves the participant's status allows and you may make. A coordinator who may not end a participant's time sees Completing a subject, withdrawing them or declaring them lost to follow-up is for the Principal Investigator.
What you can do
| From | Can move to |
|---|---|
| screening | enrolled, screen failed |
| enrolled | active, randomization failed, withdrawn, lost to follow up |
| active | completed, withdrawn, lost to follow up |
| screen failed | (none: final) |
| randomization failed | (none: final) |
| completed | (none: final) |
| withdrawn | (none: final) |
| lost to follow up | (none: final) |
| Move | From | What it asks | What it does |
|---|---|---|---|
| Enrolled | Screening | (a dedicated Enroll flow, not this menu) | See Enroll a participant. Locked in the menu until the investigator has confirmed eligibility |
| Active | Enrolled | Nothing | The participant is being followed: randomized, or enrolled in a study that is not randomized |
| Completed | Active | Completion date, and an acknowledgement if anything is open | The participant finished the study. Mark this subject Completed? lists Still open for this subject: queries not yet closed, forms complete but unsigned, serious adverse event follow-up reports still due. Tick I confirm the items above are known and will be resolved after completion, or Nothing is open |
| Withdrawn | Enrolled, Active | Reason (Adverse Event, Death, Withdrawal by Subject, Physician Decision, Protocol Violation, Lack of Efficacy, Pregnancy, Study Terminated by Sponsor, Other), Additional detail, Effective date, Safety follow-up after the withdrawal | Visit instances after the effective date will be marked as Missed unless completed. The safety follow-up is Not recorded yet, None needed, Follow-up required or Follow-up completed; the study's obligation to ask after the participant's health does not end with withdrawal |
| Lost to follow-up | Enrolled, Active | Reason (Could not be reached after repeated attempts, Moved away, Stopped attending visits, Whereabouts unknown, Other), detail (What was tried, and when), date | The site can no longer reach this subject. Record the attempts to reach them as contacts first |
| Screen failed | Screening | Reason, Specific criterion (such as Inc-3), Detail | The participant is not enrolled; the screening data is kept. Made by the investigator's ineligible determination |
| Randomization failed | Enrolled | Reason, detail | This enrolled subject was never randomized. They will not receive a treatment arm (ARMNRS = NOT ASSIGNED). Captured data is retained. A randomized study only |
Every move needs a reason where the table says so, and the participant's page shows the new status at once.
- Completes the participant after the acknowledgement.
Every option
What each status allows
| Status | Data capture | Final? |
|---|---|---|
| Screening, Enrolled, Active | Yes | No |
| Completed | Only a correction made by answering a query on an existing record | Yes |
| Withdrawn, Lost to follow-up | Same: a correction through a live query | Yes |
| Screen failed, Randomization failed | No | Yes |
A participant who no longer takes data accepts a save on an existing record only while it carries a live query raised by someone else, and only to correct it, with a reason; no new record is created for them.
Withdrawal versus lost to follow-up
A participant who chooses to leave is withdrawn. A participant the site can no longer reach is lost to follow-up, an exit of its own, not a withdrawal. Record the attempts as contacts on the participant's page before declaring it.
What the system records
subject.transitioned with the old and new status, the reason, the detail, the date and the person; for a withdrawal the safety follow-up state (subject.safety_follow_up_completed when it is later completed). See Audit events.
What you cannot do, and why
- Undo a final status. Completed, withdrawn, lost to follow-up and the two failures are final.
- Skip a status, for example complete a participant who is only enrolled.
- Move a participant with no reason where one is asked.
- Complete a participant without acknowledging what is open. The list is shown so nothing is hidden.
- Do these moves as a coordinator, unless your role holds
subject.delete.
Compliance Q&A
Yes. A withdrawal carries a coded reason, detail, an effective date and whether a safety follow-up is owed; a loss to follow-up carries what was tried; a completion lists what is still open and requires an acknowledgement; each move is attributed and final.
Evidence: client lib/cdms/subjects/exits.ts (withdrawal reasons, follow-up state)server subject-lifecycle and transition-subjectaudit event subject.transitioned
Related
Enroll a participant · Record an adverse event · Correct data · Statuses · Principal Investigator