Trialion ships 15 standard roles. They cannot be edited or deleted, and each is a fixed bundle of permissions built so that no single role can both create a problem and sign it off. One page for each role says where that person works, what they can do, what they cannot do and why, what the system records about them, and what the study simulation saw them do. The permissions, screens and rules on those pages are generated from the role catalog, so they cannot say what the system does not enforce.
An organization can also compose custom roles from the same permission set (Manage organization roles). Some things are refused outright, whoever is editing and whatever reason is given: a permission the system does not define, a permission the role's scope cannot hold, the investigator-only permissions in a role that is not an investigator's, adding to a role you hold yourself, and two separation-of-duties pairs:
- A role cannot both raise and answer queries: the person who flags a discrepancy must not be the one who resolves it.
- A role cannot both enter clinical data and lock it: entry and lock are separate duties.
The three levels
| Level | What it means | Roles |
|---|---|---|
| The organization | Applies everywhere in the organization | Organization Admin |
| One study | Given to a person on a study's team, in UAT and Live together | Project Manager, eCRF Designer, Data Manager, Clinical Data Coordinator, Clinical Research Associate, Site Monitor, Medical Officer, Sponsor Manager, Sponsor Supply Manager, Regulatory Manager, Auditor |
| One site | Given to site personnel on one site of a study; the site's principal investigator signs each delegation | Principal Investigator, Clinical Research Coordinator, Pharmacy |
A person has one role on a study. The Sponsor Manager and Sponsor Supply Manager are external: sponsor staff are invited to one study and are never members of the organization. Organization members are never site staff.
The roles
| Role | Short | Level | Permissions | In one line |
|---|---|---|---|---|
| Organization Admin | OA | Organization | 48 | Governs people, roles and studies; creates and archives studies; holds no study role and never enters or signs data |
| Project Manager | PM | Study | 42 | Runs the study; staffs it, opens its sites, takes versions to Live; signs as author |
| eCRF Designer | ED | Study | 12 | Builds forms, visits and the mapping; sees no participant data |
| Data Manager | DM | Study | 22 | Owns data quality: queries, the SDV plan, exports; signs as QA |
| Clinical Data Coordinator | CDC | Study | 10 | Closes answered queries |
| Clinical Research Associate | CRA | Study | 16 | The monitor: verifies data against source and raises queries |
| Site Monitor | STM | Study | 11 | Oversees site conduct and raises queries |
| Medical Officer | MO | Study | 15 | Reviews serious events, raises and closes medical queries |
| Regulatory Manager | RM | Study | 9 | Owns the document register and the submission exports |
| Sponsor Manager | SM | Study (external) | 13 | Reads everything; signs as approver |
| Sponsor Supply Manager | SSM | Study (external) | 8 | Read-only oversight with a supply focus |
| Auditor | AUD | Study | 13 | Reads everything, verifies the audit trail's integrity, changes nothing |
| Principal Investigator | PI | Site | 24 | The investigator of record: eligibility, delegation, the investigator signature |
| Clinical Research Coordinator | CRC | Site | 19 | Screens, enrolls, enters data, answers queries |
| Pharmacy | PH | Site | 9 | Records dispensing and accountability only |
The exact permission each role holds is on Roles and permissions and can be explored in the Roles hub; 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; every screen and who sees it is on Screens.
A role is given where it works
A study role is given on the study's team by the Project Manager; a site role on the site's staff, and it takes effect only when the principal investigator signs the delegation; an organization-wide role at the door, when an administrator invites a person. Study roles, including the operational ones, can be given on a study that is still in Setup. See Staff a study team, Staff a site and Invite and manage members.