Guides by role

Guides are grouped by role: coordinator, monitor, data manager, investigator, medical monitor and coder, administrator, QA and inspection, sponsor. Each guide page answers one “how do I …” question and follows the same shape: who needs it and when, what to prepare, the steps, what happens in the system, and what to do if it doesn’t work.

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I'm a site coordinatorCoordinator

• Enrol a subject
• Open a visit and a form in the casebook
• Enter data in a form

I'm a monitorMonitor

• Verify source data (SDV)
• Manage queries
• Export data

I'm a data managerData manager

• Build forms in the CRF builder
• Set up edit checks
• Publish a version and launch the study

I'm an investigatorInvestigator

• Sign data
• Export data

I'm a medical monitor or coderMedical monitor & coder

• Perform a medical review
• Code terms
• Manage queries

I'm an administratorAdministrator

• Manage team access
• Give an inspector access

I'm QA or an inspectorQA & inspection

• Assemble the inspection packet
• Export the audit trail
• Verify the audit chain integrity

I'm a sponsorSponsor

• How to read the study progress screen

Tasks shared by several roles

Some tasks are shared: queries are handled by the monitor, the data manager and the medical monitor; exports are made by the data manager, the monitor and the investigator. Such pages live under the role for which the task is primary and are listed in the other roles’ “Your day”.

The concepts guides rely on are in How it works; exact status and permission values are in the reference.