Roles and permissions · Trialion Docs

What this is, and who it is for

Access in Trialion is decided by permissions. A role is a named set of permissions, and a person is given a role on the organization, on a study or at a site. This page lists the 15 standard roles and the 68 permissions they are made from, exactly as the system holds them. The rules that sit on top of the roles (who may not hold two seats, who may not act on their own work) are on Who can and cannot; what each role does day to day is under Roles.

Where to find it

Roles & Permissions in the main menu (an Organization Admin; the permission is rbac.manage) lists the standard roles and the organization's own, and is where a custom role is drawn up. A person's own permissions are shown by what the screens offer them. The interactive explorer below lights up what a role holds, or who holds a permission.

Interactive · Permission & RBAC ExplorerOpen full screen →

Permission	OA	PM	ED	CRA	DM	MO	SM	SSM	AUD	PI	CRC	PH	STM	CDC	RM
Studies
`study.read`
`study.write`
`study.create`
`study.state.change`
`study.lock`
`study.archive`
Versioning
`study.version.read`
`study.amendment.start`
`study.version.submit_uat`
`study.uat.close_cycle`
`study.uat_issue.read`
`study.uat_issue.write`
`study.version.signoff`
`study.version.go_live`
`study.version.withdraw`
Sites
`site.read`
`site.write`
`site.activate`
`site.transition`
Subjects
`subject.read`
`subject.write`
`subject.delete`
`clinical.contact.write`
`clinical.consent.write`
`subject.eligibility`
Visits
`visit.read`
`visit.write`
Forms
`form.read`
`form.write`
`form.design`
`form.publish`
`form.freeze`
`form.write_dispensing`
Queries
`clinical.query.read`
`clinical.query.raise`
`clinical.query.answer`
`clinical.query.close`
`clinical.query.reopen`
Monitoring
`sdv.configure`
`sdv.perform`
Audit
`audit.read`
`audit.verify`
Exports
`export.read`
`export.run`
Admin
`rbac.manage`
`user.manage`
`system.monitor`
`org.audit.read`
`org.read`
`org.manage`
`user.directory.read`
Workflow
`workflow.design`
E-Sign
`signature.sign`
Documents
`document.read`
`document.write`
`document.manage`
Team
`team.assign`
`team.manage`
`team.training_complete`
`delegation.sign`
Library
`library.write`
AI
`ai.generate`
Safety
`clinical.event.read`
`clinical.event.write`
`clinical.event.report`
`clinical.event.review`
`clinical.event.reconcile`
`deviation.report`

Click a role (column) to see everything it can do, or a permission (row) to see who holds it. Access is further narrowed by study membership, site scope, and environment (ABAC).

What you can do

Read the standard roles and permissions (this page, or the Roles & Permissions screen).
Create a custom role from a standard role as its starting point, adding or removing permissions within the rules below (Manage organization roles). A role has the level of the role it starts from, and the setup wizard creates a set of up to 40 roles together, all of it or none of it.
Suspend and restore a custom role, and change it; each change is kept as a revision with the reason.
Ask the role assistant for suggestions of permissions that fit a role and for an explanation of a warning. It decides nothing: what it proposes is checked like anything typed (Not built yet says what the AI does and does not do).

Every option

The standard roles

A standard role is a template in the code, with a version that changes whenever its permissions do. It cannot be changed or suspended by anyone; a custom role starts from one. The number is how many of the 68 permissions the role holds.

Role	Identifier	Short	Held at	Permissions	What it is for
Organization Admin	`org_admin`	OA	The organization	48	Governs org users, the role catalog, and studies with read-only clinical oversight.
Project Manager	`project_manager`	PM	One study	42	Runs study execution — staffs the team, creates sites, tracks quality; can raise queries.
eCRF Designer	`ecrf_designer`	ED	One study	12	Builds forms, libraries, mappings. No clinical data access.
Clinical Research Associate	`cra`	CRA	One study	16	Monitors site data quality (SDV), views data, raises queries (cannot edit or answer).
Data Manager	`data_manager`	DM	One study	22	Cleans data, owns queries (raise/close/reopen), runs exports.
Medical Officer	`medical_monitor`	MO	One study	15	Reviews safety/AE and manages medical queries.
Sponsor Manager	`sponsor`	SM	One study	13	Read-only portfolio / enrollment oversight.
Sponsor Supply Manager	`sponsor_supply`	SSM	One study	8	Read-only supply-focused oversight.
Auditor	`auditor`	AUD	One study	13	Read access plus the full audit trail. Read-only.
Principal Investigator	`pi`	PI	One site	24	Site investigator-of-record — enters/verifies data, answers queries, applies the investigator e-signature.
Clinical Research Coordinator	`crc`	CRC	One site	19	Site coordinator — enters data, answers queries; no investigator signature.
Pharmacy	`pharmacy`	PH	One site	9	Drug dispensing / accountability; answers dispensing queries.
Site Monitor	`site_monitor`	STM	One study	11	Oversees site regulatory compliance, monitors protocol adherence, and raises queries on site performance.
Clinical Data Coordinator	`clinical_data_coordinator`	CDC	One study	10	Supports data cleaning and query resolution; entry-level data management.
Regulatory Manager	`regulatory_manager`	RM	One study	9	Manages regulatory document submissions and compliance tracking.

Where a permission is held

Level	Meaning
organization	Held by a role of the organization as a whole
study	Held through a role on one study
site	Held through a role at one site. Data entry is held here and nowhere else

A permission held at the wrong level does not count: a role cannot carry a permission its level does not allow, and a grant of the wrong level confers none of it.

Risk

27 of the 68 permissions are above standard risk (elevated or critical). They are governance permissions: every decision to allow them is written to the audit trail, and a person who does not hold one cannot pass it on to someone else. The custom-role editor warns when a role holds them.

The permission catalogue

Role short names: OA Organization Admin · PM Project Manager · ED eCRF Designer · CRA Clinical Research Associate · DM Data Manager · MO Medical Officer · SM Sponsor Manager · SSM Sponsor Supply Manager · AUD Auditor · PI Principal Investigator · CRC Clinical Research Coordinator · PH Pharmacy · STM Site Monitor · CDC Clinical Data Coordinator · RM Regulatory Manager.

Studies

Permission	What it allows	Held at	Risk	Rules	Held by
`study.read`	View study details and dashboards	organization, study, site	standard	none	Every role
`study.write`	Edit study settings and teams	organization, study	standard	none	OA, PM
`study.create`	Create a new study	organization, study	elevated	none	OA
`study.state.change`	Hold, resume, close to enrollment and complete a study	organization, study	elevated	separation of duties: enter-vs-lock, side B	OA, PM
`study.lock`	Lock and unlock the study database (two different people, each with an e-signature)	organization, study	critical	e-signature; separation of duties: enter-vs-lock, side B	OA, PM
`study.archive`	Archive / retire a study (soft-delete)	organization, study	elevated	none	OA

Versioning

Permission	What it allows	Held at	Risk	Rules	Held by
`study.version.read`	View the study's versions: the version list, UAT cycles, sign-offs and the changes between versions	organization, study	standard	none	OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM
`study.amendment.start`	Start an amendment (the next version of a Live study)	organization, study	elevated	none	OA, PM
`study.version.submit_uat`	Submit a version in Build to UAT (freezes its design and opens a UAT cycle)	organization, study	elevated	none	OA, PM
`study.uat.close_cycle`	Pass or fail the open UAT cycle (a failed cycle returns the version to Build)	organization, study	elevated	none	OA, PM
`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	none	OA, PM, ED, CRA, DM, SM, AUD, PI, CRC
`study.uat_issue.write`	Raise, edit, resolve, accept and reopen the issues of the open UAT cycle	organization, study, site	standard	none	OA, PM, CRA, DM, PI, CRC
`study.version.signoff`	Sign off a version that passed UAT (author, QA or approver; three different people)	organization, study	critical	e-signature	PM, DM, SM
`study.version.go_live`	Take an approved version Live (supersedes the version that was Live)	organization, study	critical	none	OA, PM
`study.version.withdraw`	Withdraw a version that has not gone Live	organization, study	elevated	none	OA, PM

Sites

Permission	What it allows	Held at	Risk	Rules	Held by
`site.read`	View site details	organization, study, site	standard	none	OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM
`site.write`	Create / edit sites and staff	organization, study	standard	none	OA, PM
`site.activate`	Activate a registered site	organization, study	elevated	none	OA, PM
`site.transition`	Transition site lifecycle (suspend / resume / close)	organization, study	elevated	none	OA, PM

Subjects

Permission	What it allows	Held at	Risk	Rules	Held by
`subject.read`	View subject data	organization, study, site	standard	none	OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC
`subject.write`	Enroll subjects, edit data	site	standard	separation of duties: enter-vs-lock, side A	PI, CRC
`subject.delete`	Withdraw / archive subjects	organization, study, site	elevated	none	OA, PI
`clinical.contact.write`	Record, and remove with a reason, a contact with a subject	site	standard	none	PI, CRC
`clinical.consent.write`	Record a subject's consent, or refusal, when an amendment asks them to consent again	site	standard	none	PI, CRC
`subject.eligibility`	Determine subject eligibility (investigator attestation)	organization, study, site	critical	investigator roles only	PI

Visits

Permission	What it allows	Held at	Risk	Rules	Held by
`visit.read`	View visit schedule and data	organization, study, site	standard	none	OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC
`visit.write`	Visit-schedule participation (visit-instance edits are gated by subject.write)	site	standard	none	PI, CRC

Forms

Permission	What it allows	Held at	Risk	Rules	Held by
`form.read`	Open forms and view answers	organization, study, site	standard	none	OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC
`form.write`	Enter / edit form data	site	standard	separation of duties: enter-vs-lock, side A	PI, CRC
`form.design`	Edit form templates in builder	organization, study	standard	none	OA, PM, ED
`form.publish`	Publish form versions to live	organization, study	standard	none	OA, PM, ED
`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, side B	OA, PM, ED
`form.write_dispensing`	Enter data on drug dispensing / accountability forms only	site	standard	separation of duties: enter-vs-lock, side A	PH

Queries

Permission	What it allows	Held at	Risk	Rules	Held by
`clinical.query.read`	View queries	organization, study, site	standard	none	OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC
`clinical.query.raise`	Open a new manual query	organization, study	standard	separation of duties: query-raise-vs-answer, side A	PM, CRA, DM, MO, STM
`clinical.query.answer`	Respond to a query on behalf of the site	site	standard	separation of duties: query-raise-vs-answer, side B	PI, CRC, PH
`clinical.query.close`	Close / resolve a query after answer reviewed	organization, study	standard	none	DM, MO, CDC
`clinical.query.reopen`	Reopen a closed query when answer is unsatisfactory	organization, study	standard	none	CRA, DM, MO

Monitoring

Permission	What it allows	Held at	Risk	Rules	Held by
`sdv.configure`	Define the SDV / risk-based targeting plan (which fields require source verification)	organization, study	standard	none	OA, PM, DM
`sdv.perform`	Verify captured data against source documents (perform SDV)	organization, study	standard	none	CRA

Audit

Permission	What it allows	Held at	Risk	Rules	Held by
`audit.read`	Access audit trail	organization, study, site	standard	none	OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM
`audit.verify`	Verify the audit-trail hash chain	organization, study	elevated	none	OA, AUD

Exports

Permission	What it allows	Held at	Risk	Rules	Held by
`export.read`	View export history	organization, study	standard	none	OA, PM, DM, SM, SSM, AUD, RM
`export.run`	Trigger ad-hoc and signed exports	organization, study	critical	none	OA, PM, DM, RM

Admin

Permission	What it allows	Held at	Risk	Rules	Held by
`rbac.manage`	Manage roles, policies, permissions	organization	critical	none	OA
`user.manage`	Invite / suspend / impersonate users	organization	critical	none	OA
`system.monitor`	View system health and queues	organization	elevated	none	OA
`org.audit.read`	Access the organization audit trail	organization	elevated	none	OA
`org.read`	View the organization and its team	organization	standard	none	OA
`org.manage`	Manage organization settings and user provisioning	organization	critical	none	OA
`user.directory.read`	Browse the organization user directory (for team staffing)	organization, study	standard	none	OA, PM

Workflow

Permission	What it allows	Held at	Risk	Rules	Held by
`workflow.design`	Build and edit workflows	organization, study	elevated	none	OA, PM, ED

E-Sign

Permission	What it allows	Held at	Risk	Rules	Held by
`signature.sign`	Apply e-signatures to records	site	critical	e-signature; investigator roles only	PI

Documents

Permission	What it allows	Held at	Risk	Rules	Held by
`document.read`	View, download, and preview study documents	organization, study, site	standard	none	Every role
`document.write`	Upload documents, add versions, edit metadata	organization, study	standard	none	OA, PM, DM, RM
`document.manage`	Approve and archive study documents	organization, study	standard	none	OA, PM, RM

Team

Permission	What it allows	Held at	Risk	Rules	Held by
`team.assign`	Assign / provision a study team role	organization, study	elevated	none	OA, PM
`team.manage`	Suspend / resume / retire team assignments	organization, study	elevated	none	OA, PM
`team.training_complete`	Mark a team member as protocol-training complete	organization, study	standard	none	OA, PM
`delegation.sign`	Sign the delegation-of-authority for a site assignment	organization, study, site	critical	e-signature; investigator roles only	PI

Library

Permission	What it allows	Held at	Risk	Rules	Held by
`library.write`	Create / edit shared library forms	organization, study	elevated	none	OA, ED

AI

Permission	What it allows	Held at	Risk	Rules	Held by
`ai.generate`	Generate or edit forms with AI	organization, study	standard	none	OA, PM, ED

Safety

Permission	What it allows	Held at	Risk	Rules	Held by
`clinical.event.read`	Read a subject’s events and the adverse event and SAE logs	organization, study, site	standard	none	OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC
`clinical.event.write`	Record, upgrade to serious, and remove an event (adverse event, concomitant medication)	site	standard	none	PI, CRC
`clinical.event.report`	Set the safety report status of a serious adverse event and its awareness time	organization, study, site	standard	none	PM, DM, MO, PI
`clinical.event.review`	Record the medical review of a serious adverse event (agreed, disagreed, or needs information)	organization, study	standard	none	MO
`clinical.event.reconcile`	Record the reconciliation of a serious adverse event with the safety database	organization, study	standard	none	PM, DM
`deviation.report`	Report and update protocol deviation status	organization, study, site	standard	none	PM, CRA, DM, MO, PI, CRC

What the system records

Creating, changing, suspending and restoring a custom role, accepting a warning with a reason, and asking the role assistant are in the organization's audit trail (rbac.custom_role.created, rbac.custom_role.updated with the earlier version kept as a revision, rbac.custom_role.suspended, rbac.custom_role.restored, rbac.custom_role.warning_overridden, rbac.ai.suggestion_requested). Every allow decision on a governance permission is recorded (authz.decision). See Audit events.

What you cannot do, and why

Change a standard role. It is a versioned template; make a custom role instead.
Give a role both sides of a separation of duties. The catalogue marks the permissions that pair; the editor refuses the role.
Put an investigator-only or site-only permission on a role that cannot hold it.
Create a role whose name is a standard role's or another's.

The full set of rules, with where each is enforced and what you see, is on Who can and cannot.

Compliance Q&A

Compliance Q&ABuiltPart 11 11.10(d)Part 11 11.10(g)Annex 11 12ICH E6 data-governance

Is access limited to authorized people, by role?

Yes. Every operation of the API declares the permissions it needs, and a request is refused before it reaches any data if the person's role at that level does not hold one. The permissions are fixed by the platform; roles are composed from them; and the table above is generated from the code, so it is what is enforced. Limits: whether the right people hold the right roles is your organization's decision and review (Review organization access and audit).

Evidence: server/src/modules/platform/rbac/domain (permission.ts, role-catalog.ts)server/src/api/middleware/authorize.tsthis page is generated from them

Compliance Q&ABuiltPart 11 11.10(g)Annex 11 12

Can a role be given both sides of a separation of duties, such as entering data and locking it?

No. Permissions on opposite sides of a pair are marked in the catalogue, and a role holding both is refused with a hard error that no administrator can accept.

Evidence: server/src/modules/platform/rbac/domain/sod.tsserver role guardrails (hard error in the role editor, whoever is editing)

Who can and cannot · Screens and who sees them · Roles · Audit events · Statuses

What this is, and who it is for#

Where to find it#

What you can do#

Every option#

The standard roles#

Where a permission is held#

Risk#

The permission catalogue#

Studies#

Versioning#

Sites#

Subjects#

Visits#

Forms#

Queries#

Monitoring#

Audit#

Exports#

Admin#

Workflow#

E-Sign#

Documents#

Team#

Library#

AI#

Safety#

What the system records#

What you cannot do, and why#

Compliance Q&A#

Related#