What this role is, and who it is for
You can see everything of the study and change nothing, and you can verify the integrity of the audit trail yourself, without asking an administrator. You are given the role on a study's team by the Project Manager (Staff a study team).
Where you work
| Where | Screens |
|---|---|
| Organization | Studies, Form Library, Settings, Library form builder |
| The study (outside UAT and Live) | Overview, Study Versions, Documents, Exports, Audit Trail |
| Build | Build (dashboard), Corrections, Amendment, Saves, Forms, Visit Schedule, Form builder |
| UAT and Live | Dashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Sites, Participants, Casebook, Queries, AE Log, SAE Log, Exports, Reports: Enrollment, Reports: Site performance, Reports: Query aging, Reports: Visit compliance, Reports: Protocol deviations, E-Signatures, Audit Trail, Site: Queries, Site: Documents, Site: Staff, Participant: Queries, Participant: AEs and medications |
| UAT only | Issues, Results |
| Live only | Site Team, Reports: Lock readiness |
- The auditor reads the trail, the signatures and the records.
What you can do
- Read the study, its sites, participants, visits, forms, queries and adverse-event logs, the casebook, the reports, the versions and the UAT issues and results, and the documents.
- Read the full audit trail and the e-signature register of each workspace and of the study, and filter and export it as CSV (Review the audit trail).
- Verify the audit trail's hash chains with Verify chain integrity: every chain of the organization, its studies and their workspaces, and a report of valid or where a chain breaks. This is the permission that matters: you can confirm independently that no audit entry has been inserted, removed or altered (Review organization access and audit).
- See and download exports others produced (the Exports page, without New export).
Every permission this role holds
13 permissions (template version 5).
| Permission | What it allows | Held at | Risk | Constraint |
|---|---|---|---|---|
audit.read | Access audit trail | organization, study, site | standard | |
audit.verify | Verify the audit-trail hash chain | organization, study | elevated | |
document.read | View, download, and preview study documents | organization, study, site | standard | |
export.read | View export history | organization, study | standard | |
form.read | Open forms and view answers | organization, study, site | standard | |
clinical.query.read | View queries | organization, study, site | standard | |
clinical.event.read | Read a subject’s events and the adverse event and SAE logs | organization, study, site | standard | |
site.read | View site details | organization, study, site | standard | |
study.read | View study details and dashboards | organization, study, site | standard | |
subject.read | View subject data | organization, study, site | standard | |
study.version.read | View the study's versions: the version list, UAT cycles, sign-offs and the changes between versions | organization, study | standard | |
study.uat_issue.read | View the issues and results of a UAT cycle (what testers found, and what became of it) | organization, study, site | standard | |
visit.read | View visit schedule and data | organization, study, site | standard |
What you cannot do, and why
- Write anything. No data entry, queries, design, state changes, signatures or new exports. The Exports page shows no New export control.
- Raise or write UAT issues: you can read them.
Why you can verify the chain yourself
Every audit entry stores a hash of itself and of the entry before it. Recomputing the chain shows that nothing was inserted, removed or altered. If only an administrator could run that check, an administrator's own actions would be unverifiable, so the permission sits with the Auditor role independently, and you do not need the cooperation of the organization you audit.
What the audit trail contains
Every recorded action carries what happened, who did it, when, the study, site and participant it concerned, and, where data changed, the earlier and new value and the reason. Open an entry for its detail, including where it sits in its chain. The trail, the events and their wording are on Audit events; how it is protected is on Audit trail and evidence.
What the system records
Reading and verifying leave no entry: the audit trail records changes and refusals, not reads, and a refused attempt is recorded as an access decision (authz.decision). See Audit events.
Seen in the simulation
Could: see the Exports list and the e-signature register (read-only). Could not: start an export. Not tried: verifying the organization's chain as the Auditor (the Organization Admin did it, and the chain verified).
Compliance Q&A
Yes. The Auditor holds read permissions and audit verification and nothing that writes. The trail itself is append-only, so even a role that could write elsewhere could not alter it.
Evidence: role-catalog auditor (read permissions plus audit.read and audit.verifyno write)audit append-only and chained
Related
Review the audit trail · Review organization access and audit · Audit trail and evidence · 21 CFR Part 11