Participants and the trial lifecycle¶

🟠 In progress

This chapter follows a participant from sign-up to the end of the trial, and explains the statuses you see in the overview.

The participant journey¶

Enrol: the participant registers for the trial and is assigned a randomisation sequence (see Enrolment and randomisation). There is a short unlock delay before they can begin.
Screening: they complete the eligibility screening questionnaire. If they are not eligible, they do not proceed.
Consent: they read the participant information sheet and agree to the consent form. The version they agreed to is recorded.
Baseline: they complete the before-treatment questionnaires.
Intervention and washout: they move through the trial’s phases: listening sessions during intervention periods, and rest during washouts (either no listening, or unmodulated listening, depending on the washout type).
Post-trial / debrief: after the last phase they complete the final questionnaire and can see their debrief.
Completion: submitting the final questionnaire completes the participant, which counts toward the trial’s completion target.

Statuses you will see¶

Registered / waiting to unlock: Signed up, not yet started.
Active: Currently taking part.
Completed: Finished the trial. Counts toward the completion target.
Withdrawn: Left the trial, or removed. Frees a recruitment place (see Enrolment and randomisation).

Dropout¶

A participant who is inactive for longer than the trial’s inactivity dropout window (set in Step 1 · Identity) is treated as dropped out. Because the enrolment count excludes withdrawn participants, a dropout also frees a recruitment place, which can let a paused trial resume.

Warning

This sweep is not scheduled. Inactivity dropouts are only applied when someone runs process_dropouts by hand, so a participant can sit inactive well past the window and still occupy a recruitment place. The same applies to process_deletion_requests, which is what actions a participant’s data-deletion request.

For what each of these stages looks like inside the app, see The participant app experience.