The whole trial, from an empty platform to an archived study. Click any phase to see the responsible role, what happens, the audit footprint, and common alternate paths — then follow the link into the detailed workflow.
Phase 1 Operation The organization is set up Platform operator · Organization Admin Phase 2 Operation The study is created and built Organization Admin · Project Manager · eCRF Designer Phase 3 Gate The design is frozen and tested in UAT Project Manager · testers Phase 4 Sign / seal Three people sign the version off, and it goes Live Project Manager · Data Manager · Sponsor Manager Phase 5 Gate Sites are opened Project Manager · Principal Investigator Phase 6 Gate Participants are enrolled Principal Investigator · Clinical Research Coordinator Phase 7 Operation Visits happen and data is captured Clinical Research Coordinator · Principal Investigator Phase 8 Operation Data is cleaned through queries Data Manager · monitors · site Phase 9 Operation Monitors verify against source Clinical Research Associate Phase 10 Operation Safety is recorded Site · Medical Officer · Data Manager Phase 11 Sign / seal Records are signed Principal Investigator Phase 12 Gate The protocol is amended Project Manager · build team Phase 13 Sign / seal The study closes and the database is locked Project Manager · two signers · Organization Admin Phase 1 / 13 Operation
The organization is set up Platform operator · Organization Admin
The operator creates the organization with its first Organization Admin. The administrator signs in from an invitation and is led through three steps: choose the roles, invite the team, create the first study.
The organization, the administrator's invitation and every role are recorded. Roles are checked for separation of duties when they are created, and the Organization Admin holds no study role. If the standard roles do not fit, a custom role is composed from permissions under guardrails; some combinations are refused for everyone. Set up your organization ← Previous Next →