User roles and permissions

Purpose

Understand how a user's role combines with Account, study, site and blinding restrictions. Learn how administrators review permission definitions without assuming that a job title grants access.

Expected outcome

You can distinguish System Admin, Account Admin and operational roles, identify the permission for a task, and escalate access requests without weakening blinded study controls.

Prerequisites

Sign in with an authorized user account.
Role management requires Roles.Manage and the appropriate administrative scope.
Any requested access should be approved under the study's access-management procedure.

Section 1: Roles and organization boundaries

Role or concept	Responsibility	Boundary
System Admin	System-level administration and Account creation/allocation.	Privileged access must be tightly governed; it is not an ordinary site role.
Account Admin	Users and profile administration within their own Account.	Cannot create another Account or manage another Account's records.
Operational role	Configured combinations of task permissions.	Study and site assignments still restrict accessible records.
Blinded role	Performs permitted workflows without ordinary treatment/product disclosure.	Unblinded visibility requires the relevant blinding permission.

Global role templates include site, monitoring, data management, supply, statistical and pharmacy responsibilities. Their actual permission definitions, not their names alone, determine available actions.

Section 2: Match permissions to actions

Subjects.Randomize: randomize an eligible screened subject.
Dispense.Execute: dispense and verify issued kits.
Inventory.Manage: manage permitted inventory workflows.
Audit.View: inspect audit records and request ledger verification.
Data.Export: export permitted reports in addition to report-specific access.
Blinding.Unblinded: treatment/product visibility; separate action permissions are still required.

Section 3: Review or configure a role

Open Roles & Permissions.
Select the authorized Account scope. System-level global templates are read-only.
Select a role and review its grouped permissions and blinding state.
For an approved Account-specific custom role, change only the permissions required by the documented responsibility and save.
Verify the resulting role assignment with an authorized test user. Saving permission changes revokes affected active sessions, requiring sign-in again.

Built-in System Admin, Account Admin and global template roles cannot be edited or deleted through this workflow.

Section 4: Quality Assurance role

Every Account includes a built-in Quality Assurance role for independent QA oversight. It is blinded and read-only: it can view studies, subjects, sites, inventory and temperature records, review the audit trail (Audit.View) and export permitted reports (Data.Export), but it cannot randomize, dispense, manage supply or change configuration.

Example: a QA auditor reviews the audit trail and exports the shipment report for a site audit without being able to see treatment assignments or modify records.

Troubleshooting and checks

If a menu is visible but an action fails, review action permission, Account/study/site scope, record state and blinding together. Physical-document operations also have named-role/type rules. Do not grant unblinded access just to make a report or supply action convenient.

Captured read-only role template showing Study, Subjects and Blinding permission groups — Captured application view · redactedA cropped subset of the built-in role template shows separate Study, Subjects and Blinding permission groups. Other groups and Account usage information are excluded. Click the image to enlarge it.

This guide supports training and does not authorize clinical decisions, override access controls or establish regulatory compliance. The approved protocol and organizational procedures remain authoritative.