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Episode 2 / 12
Trial Management: the schedule, the visits, and a verdict
Participants, visit schedules and protocol windows. Every completed visit gets a verdict (in window, early or late), and an out-of-window visit files its own deviation.
About this episode
Your day
- A coordinator's day is participants and visits. Who is due, who came late, and who was missed.
- In MAESTRO, that is Trial Management: trials, sites, investigators, participants, visits and milestones.
Participants
- Add a participant, and MAESTRO assigns the ID itself: the site number, then the next number in line.
- It stores initials, and the month and year of birth. No name, and no full birth date.
Schedule
- Copy the sponsor's visit schedule into MAESTRO's Excel template. Upload it, preview it, then confirm.
- Once the template is approved, Bulk Assign schedules a whole cohort in four steps.
- Each participant gets a visit for every timepoint, counted from their own anchor date.
Visits
- Mark a visit completed, and MAESTRO checks it against its window: in window, early, or late.
- Outside the window, it files a deviation by itself, graded from minor to critical.
- Mark a visit as missed, and MAESTRO files a critical deviation for it, by itself.
- When the protocol is amended, activate the new schedule version. Open schedules receive only the difference.
- New visits appear, and removed ones are marked Superseded.
Reports
- The dashboard shows upcoming visits, enrollment progress, and open schedule deviations.
- The visit window compliance report counts missed visits too, and shows its formula on screen.
- A visit cannot be completed while its services are still open. And its changes are kept in the audit trail.
Trial Management in MAESTRO: the schedule, the visits, and a verdict on every scheduled visit you complete.
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