What this role is, and who it is for
The Organization Admin governs people, roles and studies across the organization, and is deliberately kept out of the clinical record. It is the only role that can create a study, the only one that can archive a locked study, and the one that holds the keys to who may do what. It holds no study role, and it never enters or signs clinical data.
An organization starts with one: the first administrator, invited by the platform operator (Set up your organization). An administrator can make a second one from the Organization Team (Invite and manage members); the organization always keeps at least one who can act.
Where you work
| Where | Screens |
|---|---|
| Organization | Studies, Form Library, Roles, Organization Team, Access, Organization Audit, Settings, Organization setup (wizard), Library form builder |
| The study (outside UAT and Live) | Overview, Study Versions, Documents, Exports, Audit Trail, Study Team, Study Settings |
| Build | Build (dashboard), Corrections, Amendment, Saves, Forms, Visit Schedule, Visit and Form Mapping, AI Workstation, Form builder |
| UAT and Live | Dashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Mapping (read-only), Sites, Participants, Casebook, Queries, AE Log, SAE Log, SDV Plan, SDV Monitoring, 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 administrator's own pages are Organization Team, Roles & Permissions, Access, Organization Audit and Settings; Studies is the home page. The setup wizard (/setup) is offered once, until it is finished.
- Only this role can create a study.
What you can do
People and access
- Invite, suspend, restore and remove people; make a second Organization Admin (Invite and manage members).
- Create, clone, edit and suspend custom roles under the guardrails (Manage organization roles).
- Read who holds what, and request, approve and end time-limited access exceptions (Review organization access and audit).
- Browse the user directory and staff study teams, mark protocol training complete, and suspend or retire assignments (
team.assign,team.manage,team.training_complete).
Studies
- Create a study and name its Project Manager. No other role can (Create a study).
- Edit the study's settings, move it through its states, and confirm the second step of a database lock or unlock; archive a locked study. Archiving is yours alone (Change the state of a study, Close and lock a study).
- Build forms, visits and the mapping alongside the designer; submit a version to UAT, close a UAT cycle, take a version Live, withdraw a version and start an amendment (Review and release a study).
- Register, activate, suspend and close sites; define the SDV plan.
- Withdraw a participant with a documented reason (
subject.delete, shared with the principal investigator: Change a participant's status).
Evidence and operations
- Read the organization audit trail and each study's, and verify the hash chains (Review the audit trail).
- Run and download exports; upload, version, approve and archive documents; read system health (
system.monitor). - Write to the form library and use the AI form generator.
Every permission this role holds
48 permissions (template version 6).
| Permission | What it allows | Held at | Risk | Constraint |
|---|---|---|---|---|
org.audit.read | Access the organization audit trail | organization | elevated | |
org.read | View the organization and its team | organization | standard | |
org.manage | Manage organization settings and user provisioning | organization | critical | |
user.manage | Invite / suspend / impersonate users | organization | critical | |
rbac.manage | Manage roles, policies, permissions | organization | critical | |
system.monitor | View system health and queues | organization | elevated | |
user.directory.read | Browse the organization user directory (for team staffing) | organization, study | standard | |
ai.generate | Generate or edit forms with AI | organization, study | standard | |
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 | |
document.write | Upload documents, add versions, edit metadata | organization, study | standard | |
document.manage | Approve and archive study documents | organization, study | standard | |
export.read | View export history | organization, study | standard | |
export.run | Trigger ad-hoc and signed exports | organization, study | critical | |
form.read | Open forms and view answers | organization, study, site | standard | |
form.design | Edit form templates in builder | organization, study | standard | |
form.publish | Publish form versions to live | organization, study | standard | |
form.freeze | Marks a role as data-locking authority (separation of duties: cannot also enter data) | organization, study | standard | separation of duties (enter-vs-lock) |
library.write | Create / edit shared library forms | organization, study | elevated | |
sdv.configure | Define the SDV / risk-based targeting plan (which fields require source verification) | organization, study | 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 | |
site.write | Create / edit sites and staff | organization, study | standard | |
site.activate | Activate a registered site | organization, study | elevated | |
site.transition | Transition site lifecycle (suspend / resume / close) | organization, study | elevated | |
study.read | View study details and dashboards | organization, study, site | standard | |
study.write | Edit study settings and teams | organization, study | standard | |
study.create | Create a new study | organization, study | elevated | |
study.state.change | Hold, resume, close to enrollment and complete a study | organization, study | elevated | separation of duties (enter-vs-lock) |
study.lock | Lock and unlock the study database (two different people, each with an e-signature) | organization, study | critical | needs an e-signature; separation of duties (enter-vs-lock) |
study.archive | Archive / retire a study (soft-delete) | organization, study | elevated | |
subject.read | View subject data | organization, study, site | standard | |
subject.delete | Withdraw / archive subjects | organization, study, site | elevated | |
team.assign | Assign / provision a study team role | organization, study | elevated | |
team.manage | Suspend / resume / retire team assignments | organization, study | elevated | |
team.training_complete | Mark a team member as protocol-training complete | organization, study | 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.amendment.start | Start an amendment (the next version of a Live study) | organization, study | elevated | |
study.version.submit_uat | Submit a version in Build to UAT (freezes its design and opens a UAT cycle) | organization, study | elevated | |
study.uat.close_cycle | Pass or fail the open UAT cycle (a failed cycle returns the version to Build) | organization, study | elevated | |
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 | |
study.uat_issue.write | Raise, edit, resolve, accept and reopen the issues of the open UAT cycle | organization, study, site | standard | |
study.version.go_live | Take an approved version Live (supersedes the version that was Live) | organization, study | critical | |
study.version.withdraw | Withdraw a version that has not gone Live | organization, study | elevated | |
visit.read | View visit schedule and data | organization, study, site | standard | |
workflow.design | Build and edit workflows | organization, study | elevated |
What you cannot do, and why
- Hold a study role. You cannot be added to a study team or named a Project Manager, and a person on a study team cannot be made an administrator until they are taken off it. The rule is enforced in the server and in the database.
- Enter or correct clinical data. You can read participants and forms; you hold no permission to write a value.
- Raise, answer or close queries. You can read them.
- Sign off a version. The three sign-offs are the Project Manager's (author), the Data Manager's (QA) and the Sponsor Manager's (approver). An administrator who could sign any of them would defeat the independence the sign-off exists to prove.
- Apply an investigator signature or sign a delegation. Only the site's principal investigator can.
- Verify data against source.
- Be given an access exception. The Organization Admin role takes none, and nobody gives themselves one.
- Suspend or remove the last administrator, including yourself when you are the only one.
What the system records
Everything you do to people, roles and studies is in the organization's audit trail: platform.user.*, rbac.custom_role.*, access.exception_*, org.onboarding.*, study.created, study.state.changed, study.lock.*, study.version.*, team.role_assigned, site.*, export.*, document.*. See Audit events.
Seen in the simulation
Could: run the onboarding wizard; read the 15 standard roles; create and edit a custom role with the AI assistant (a reason is required and revisions are kept); invite members; suspend a member; read the organization audit and verify its chain; create a study; confirm the second step of a lock and an unlock; archive a locked study. Could not: hold a study role (the Study Team row is disabled; the API answers 422 team.separation_rule); sign a version (no Sign off control); be removed or suspended as the last administrator; be added to a study team as Data Manager.
Compliance Q&A
Yes. The Organization Admin holds no permission to write or sign clinical data, cannot hold a study role, and cannot sign a version. These are enforced by the server and by the database, not by the screens.
Limits: an organization can still give one person both an administrator seat and, through a different identity, a study seat. Who is who is decided by the organization's invitation procedure.
Evidence: role-catalog org_admin (no form.write, no signature.sign, no study role)database rule cdms_org_admin_holds_no_team_rolesimulation of 20 Oct 2026 (Study Team row disabled, 422 team.separation_rule)
Related
Set up your organization · Manage organization roles · Invite and manage members · Create a study · Who can and cannot · Roles and permissions