Roles and permissions

Trialflare uses role-based access control (RBAC) so you can decide exactly what each staff member can see and do. There is no single “role” enum baked into the product for every customer; instead, named roles (optional) bundle permissions, and you can also assign individual permissions at the right scope (whole trial, a site, or a participant group).

This page lists the permission keys the Trialflare web app uses when you configure collaborators, sites, and groups. The descriptions match the in-product permission chooser.

How it fits together

  • Team — Users belong to your organisation’s team. Only team members can be added as trial collaborators. Team-level permissions (users.*, trials.*, team.*) control invitations, trial creation, and account administration separately from trial scope.
  • Trial — Most capabilities are controlled with trial.* permissions on that trial.
  • Sites — For multi-site studies, site.* permissions can limit access to one site’s participants, files, and packs.
  • Groups — Study arms or cohorts can use group.* permissions so someone only sees (or edits) participants in that group.

Roles are reusable bundles of these permissions (configured under trial personnel / roles). Assigning a role is a shortcut; the effective access is still expressed as a set of permission keys.

Baseline trial access

When someone is first added as a collaborator, the system may grant a minimal baseline such as trial.access so they can open the trial at all. That key is treated as a system-style gate and is not listed in the chooser alongside the fine-grained permissions below—but other permissions still govern what they can actually do once inside.

PII and sensitivity

Several descriptions call out PII (personally identifiable information) or restricted study fields. Trialflare separates “ordinary” study data from more sensitive views so you can comply with least-privilege and delegation norms (e.g. monitors who must not see direct identifiers).

Trial permissions (trial.*)

These apply to the trial as a whole (unless combined with site- or group-scoped grants).

Permission Description
trial.admin Trial administrator (full access) (no-PII)
trial.read Trial-wide admin view access (no-PII)
trial.write Trial-wide admin write access
trial.readParticipants List all participants in the trial
trial.registerParticipants Register new participants into the trial
trial.writeParticipants Edit participant details (name, email, phone, ID)
trial.allocateParticipants Mark participants as allocated or unallocated
trial.archiveParticipants Archive and unarchive participants
trial.withdrawParticipants Mark participants as withdrawn
trial.deleteParticipants Permanently delete participants and their data
trial.tagParticipants Add and remove participants from groups (tags)
trial.randomiseParticipants Randomise participants into a study arm, from the sequence set up under Participants > Randomisation (also allowed for trial admins; on its own it doesn't show which arm)
trial.breakCode Break the code in an emergency: see one participant's study arm, once, with a reason. Recorded in the event log, marked on the participant and emailed to the trial admins, in a study that conceals its allocation (not implied by trial admin)
trial.readAllocation See which study arm a participant is in, and put participants into an arm or take them out, in a study that conceals its allocation; download the allocation record (not implied by trial admin)
trial.rescheduleParticipants Manually reschedule participant stages and tasks on the timeline
trial.readParticipantPersonalInformation View participant personal profile and contact details (PII)
trial.readParticipantConsent View a participant’s consent information (PII)
trial.readTrialConsents List all trial consents (PII), and — with trial.read — the consent sessions behind them
trial.readConsentSettings View-only access to consent settings (availability and informed consent forms)
trial.readTrialSettings View-only access to trial settings and the About tab
trial.readDataTypes View-only access to the Data Types configuration
trial.readStages View-only access to the Stages configuration
trial.readParticipantNotes View participant notes and communication logs
trial.writeParticipantNotes Add notes to participants
trial.readParticipantStudyData View participant study data (excluding restricted and PII fields)
trial.readParticipantStudyDataRestricted View restricted participant study data fields (restricted)
trial.readParticipantStudyDataPii View PII participant study data fields (PII)
trial.writeParticipantStudyData Create and update study data for every participant in the trial
trial.exportData Export / bulk-download trial data from the Results tab
trial.readFiles View all files in the eTMF
trial.readApprovedFiles View approved files only in the eTMF
trial.readFileVersions View file versions in the eTMF
trial.writeFiles Create new files and versions in the eTMF
trial.deleteFiles Delete all files and versions in the eTMF
trial.requestFileApproval Request eTMF file approval
trial.approveFiles Approve all eTMF files
trial.readUsers View trial users
trial.support Send and receive support messages
trial.readTasks List all trial tasks (without it, people see only the tasks assigned to them)
trial.writeTasks Create and manage trial tasks, including reading them
trial.readQueries List all trial queries
trial.writeQueries Raise trial queries
trial.readAutomaticQueries View automatic trial queries
trial.writeAutomaticQueries Create automatic trial queries
trial.readSites View trial sites
trial.writeSites Create and update trial sites
trial.listPacks List and view packs
trial.writePacks Create and update packs
trial.deletePacks Delete packs
trial.assignPacks List and assign available packs to participants
trial.createParticipantMeetings Create online video call meetings with participants
trial.readParticipantMeetings View online video call meetings with participants
trial.joinParticipantMeetings Join participant video call meetings
trial.deleteParticipantMeetings Delete online video call meetings with participants
trial.manageWallet Manage (view and top-up) the trial wallet
trial.useAssistant Use the trial assistant
trial.readInsights View trial and participant insights
trial.readLogs View and export the trial's event log (Settings > Audit > Logs) without being an administrator. What the entries show of participants' personal information and of restricted/PII field values still follows the viewer's own keys
trial.signResponses Electronically sign responses and casebooks as the investigator. Not implied by trial.admin — grant it to the investigator explicitly
trial.readSiteMessages Read all site message boards in the trial
trial.writeSiteMessages Post to any site message board and broadcast to all sites

Configuration: view-only, write, and admin

Trial configuration — stages, stage groups, and data types — is editable with trial.write (admin-level write access). Only top-level governance actions require trial.admin: locking/unlocking the trial or database, editing trial settings, managing consent settings, and deleting the trial. Reading the event log needs trial.admin or trial.readLogs.

If someone should see configuration without changing it, grant the matching view-only key instead: trial.readStages, trial.readDataTypes, trial.readTrialSettings, or trial.readConsentSettings. Each is implied by trial.read, so a trial-wide viewer already has them.

Study data: viewing vs. exporting

Study data has three layers, and viewing is separate from exporting:

  • trial.readParticipantStudyData — view study data (excluding restricted and PII fields). This governs both a participant's Responses tab and the trial-wide Results tab (Dashboards and Explore). Add trial.readParticipantStudyDataRestricted and trial.readParticipantStudyDataPii for those field layers.
  • trial.exportData — the additional, more sensitive bulk export/download action (the Export tab in Results, and raw data exports). It falls through to trial.read, so existing trial-wide readers keep export; grant it explicitly to give export without full trial.read.

Because they're separate, trial.readParticipantStudyData on its own means "can view Results but cannot export"; add trial.exportData for a role that should also download. Export still requires the relevant study-data read permission for the data being exported.

Site-scoped staff (site.readParticipants + site.writeParticipantStudyData) can view and edit the study data of participants in their site without any of these trial-wide keys — that access follows the participant, not the trial-wide Results/export surface. site.write also allows this, along with the site's tasks, its message board and adding or removing its participants, so prefer site.writeParticipantStudyData for someone who only enters data. Don't give site staff trial.writeParticipantStudyData for this: it isn't limited to their site, and lets them write to any participant in the trial.

Messaging: site boards vs. participant support

Two separate features both involve “messages”, and they use different permissions:

  • Site message boards (staff-to-staff, per site) — trial.readSiteMessages / trial.writeSiteMessages (trial-wide, all boards) and site.readSiteMessages / site.writeSiteMessages (a single site’s board).
  • Participant support messaging (staff-to-participant) — trial.support.

Tasks: the whole board vs. one site's tasks

  • trial.readTasks / trial.writeTasks cover every task in the study.
  • site.readTasks / site.writeTasks cover the tasks for one site. A task can be for one or more sites; tasks for queries take the participant's sites, and tasks for site monitoring issues take the issue's site. Someone with site.writeTasks can only create tasks for the sites they hold it on, and can only assign them to staff of the task's sites they hold it on: members (site.access), and anyone given site.read, site.write, site.readTasks or site.writeTasks there. A task with no site is seen only by people with the trial-wide keys. site.read and site.write include the site's tasks.
  • Anyone else with access to the study sees only the tasks assigned to them. They can move and complete them, but not reassign or delete them.

Site permissions (site.*)

Use these when someone should only operate within one site (participants, files, packs scoped to that site).

Permission Description
site.access Be a site member (recommended for any site roles)
site.read Site-wide admin view access, including the site's files and their version history
site.write Site-wide admin write access. Includes everything site.read does, but changing files still needs the file keys below
site.readParticipants List all participants at the site
site.writeParticipantStudyData Create and update study data for participants at the site
site.registerParticipants Register new participants and add them to this site
site.readFiles Read site files
site.readApprovedFiles View approved site files only. Don't combine it with site.read or site.write, which show every file at the site
site.readFileVersions View site file versions
site.writeFiles Create new site files and versions
site.deleteFiles Delete site files and versions
site.requestFileApproval Request site file approval
site.approveFiles Approve site files
site.readUsers View site personnel
site.listPacks List and view packs
site.writePacks Create and update packs
site.assignPacks List and assign available packs to participants
site.readSiteMessages Read this site’s message board
site.writeSiteMessages Post to this site’s message board
site.readTasks View the tasks for this site
site.writeTasks Create and manage the tasks for this site

Group permissions (group.*)

For study arms / groups of participants:

Permission Description
group.read Read group participants and data
group.write Read and change group participant data

Practical tips

  1. Start narrow — Grant trial.readParticipantStudyData without PII/restricted keys until a user truly needs those layers.
  2. Use sites — Combine site.access with read/write participant and file permissions so local staff only see their own site’s cohort.
  3. Separate approvers — Split trial.writeFiles / trial.requestFileApproval from trial.approveFiles where regulations require independent QC.
  4. Wallet and meetings — trial.manageWallet and the participant-meeting permissions are distinct; a coordinator who runs visits need not be able to top up incentives (or vice versa).

For workflow context on adding collaborators and sites, see Part 10 — Team members, collaborators and sites.