Study overview and settings

Set-up steps, launch, lock, blinding.

Set-up steps

The study overview lists the steps: sites, principal investigators, team, blinding. Finished steps tick themselves.

Statuses

• Setting up: everything can change.
• Enrolling: the study is launched and the launch date is in the audit trail.
• Database locked: no changes. Only the manager locks and unlocks, with a password and a reason.

Settings

Name, sponsor, target number of subjects, subject number prefix and the “blinded study” flag. In a blinded study team members do not see treatment allocation by default; unblinding is set per person in the team.