Roles and permissions

What each of the 14 roles can see and do, and why a page may be missing from your screen.

Every Trelice account has exactly one role. Your role decides which pages appear in your left-hand menu, which buttons you can press, and which roles you may hand out to others. This page lists all 14 roles, from highest authority to lowest, and then explains the second thing that shapes your screen: your organization's products.

The 14 roles#

The order below matters: it is the official ranking, highest first. An administrator can only assign roles at or below their own rank, and cannot change an account that outranks them — see Managing users and invitations.

Rank	Role	What you can see and do
1	Platform Administrator	Runs the Trelice platform itself, across all customer organizations. Sees the Tenants page and everything else. Ordinary organizations never have this role.
2	System Administrator	Full control inside their organization. Sees the whole Administration menu group — Users, Templates, Review Workflows, Abbreviations, Redaction, Budget Pricing — plus the audit trail, and can do everything writers and reviewers can.
3	Sponsor Administrator	Runs the sponsor organization's day-to-day: same Administration menu group as a System Administrator, manages studies and protocols, and reads the audit trail. Cannot create or manage System Administrators.
4	Regulatory Affairs	Reviews compliance and submission readiness. Can create studies, write and review protocol and consent form sections, manage amendments and sites, adjust redaction, and read the audit trail — the only non-administrator role that can.
5	Medical Monitor	Oversees safety. Reviews sections, works on visit instructions, and takes part in review workflows wherever safety judgment is needed.
6	Biostatistician	Authors and reviews the statistical parts of a protocol — analysis plans, sample size — and serves as a reviewer for related sections.
7	Medical Writer	The primary author. Drafts and revises protocol sections, consent forms, and other study documents, and sends them for review.
8	Clinical Operations	Manages the practical side: sites, IRBs, and study logistics. Can review sections for operational feasibility.
9	Drug Safety	Reviews pharmacovigilance content — safety data and risk management plans — as a section reviewer.
10	Clinical Supply	Looks after investigational product supply, packaging, and distribution; reviews the sections that touch those topics.
11	Principal Investigator	The doctor leading a trial site. Reads protocols and reviews sections assigned to them.
12	IRB / Ethics Reviewer	Reviews for ethical compliance and participant protection, including the ethics steps of an amendment.
13	Language Specialist	Reviews translated consent form content. Only appears as a reviewer choice for languages listed in their language specialties — see Translations and country versions.
14	Read-Only Viewer	Can open and read studies and protocols, but cannot edit, review, or approve anything.

A few gates worth knowing#

The Administration menu group (Users, Templates, Review Workflows, Abbreviations, Redaction, Budget Pricing) appears only for System Administrators and Sponsor Administrators (and Platform Administrators).
The audit trail can be read by administrators and Regulatory Affairs. Other roles will find the Audit Trail page empty of data even though the menu item is visible.
Creating studies is for administrators and Regulatory Affairs; writing protocol content is chiefly for Medical Writers and Regulatory Affairs, with Biostatisticians and Clinical Operations able to edit the sections in their specialty.
Being a reviewer is open to nearly every role — a review workflow or a section's required reviewer roles decide who is actually asked. See Setting up review workflows.
Handing out roles follows the rank rule above: nobody can grant a role higher than their own, and nobody can modify an account above their own rank.

Products: the other reason a page may be missing#

Trelice is sold in three parts, called products. Your organization has only the products its contract covers:

Protocol Authoring — studies, the protocol editor, reviews, amendments, and the derived study documents.
ICF Master — creating and managing the master consent form.
ICF Country — country-specific consent forms with translation, and the ICF Generator.

A missing product hides its pages entirely, for every role in the organization.

Note: In short — if a page described in these guides is missing from your screen, your organization may not have that product, or your role may not include it. Neither is an error. Your administrator can tell you which applies; administrators themselves can check products with the platform team.

Troubleshooting: Not sure what role you have? Look at the bottom of the left-hand menu — your name and role are shown there. See Finding your way around. For quick answers to "where did that button go?", see Common questions and problems.