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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  • New visits appear, and removed ones are marked Superseded.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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