What this is, and who it is for
The study team is the people who hold a role on this study: the Project Manager, the eCRF Designer, the Data Manager, monitors, the Medical Officer, sponsor staff, an auditor. It is made from your Organization Team. Site staff are not on it: they are added inside their site, and become able to work when the site's principal investigator signs their delegation (Staff a site).
A person has one role on a study, and holds it in both workspaces (UAT and Live): one assignment gives both.
| You need | To |
|---|---|
study.write or user.manage | see the Study Team page |
team.assign | add a member |
team.manage | pause, resume or end a role |
team.training_complete | mark a person's training complete |
Held by: Organization Admin, Project Manager (team.assign).
A Project Manager staffs the study without a breakpoint: any study or site role may be added at any time, including in Setup. The only comparison is that nobody may give themselves a role carrying a permission they do not already hold.
Where to find it
Study → Study Team (at the study level). The page header reads Who holds a role on this study, and who works at its sites. A person has one role on a study, held in UAT and in Live: one assignment gives both. A banner repeats it: Adding someone gives them the one role in both workspaces. Nothing the UAT team enters reaches the live database. The first release is refused while an active production site has no Investigator.
What you can do
Add people from your organization
- Choose Add members. The first tab is People from your organization: search by name or email, tick the people, and choose Their role on this study for each. Only study roles are listed. The tag beside a name is the person's role in the organization.
- The dialog's What happens next says each person is added in UAT and Live and gets an email. Confirm.
- A toast says how many were added; if some could not be, it says which and why (Could not assign — …).
An Organization Admin cannot be added: they govern the organization and hold no study role.
- The first tab: people who are already in the organization.
- The second tab: people outside the organization, for the two sponsor roles.
Add sponsor staff
The second tab, Add sponsor staff, is for people who work for the sponsor, not your organization: give their Full name, Work email and role. Only the two sponsor roles are offered: the Sponsor Manager, who oversees the study read-only and gives the approving signature at go-live, and the Sponsor Supply Manager. Sponsor staff are on this study only, are not on your Organization Team, and see only what the sponsor roles may see.
- The person's name.
- An address outside the organization: an organization address is refused inline.
Read the team
The page has three tabs, each with a count: Study Team, UAT Site Staff and Live Site Staff. A strip of figures shows the number of people, how many can work and how many are trained. Search by name or email. The Study Team table has one row for each person:
| Column | What it shows |
|---|---|
| Member | Name and address, with a Sponsor tag for sponsor staff |
| Role | The role held |
| Status | Whether the person can work, and why not if they cannot (a role paused, a site not active, a delegation not signed) |
| Email status | What became of the mail that told them: queued, sent, delivered, bounced, failed. A problem is explained, with what to do, in a small dialog. No email was sent is shown when none was |
| Actions | The menu below |
The site tabs list each site's staff with Person, Role, Can work, Training (Complete or Pending; it blocks nothing), Email status.
- Opens the Add members dialog.
Pause, resume, end, train
Each row's Actions menu offers, depending on your permissions and the row's state:
| Action | Effect |
|---|---|
| Pause role | Temporarily suspends the assignment. Asks a reason, recorded against the assignment |
| Resume role | Reinstates a paused assignment |
| Mark training complete | Sets the person's training flag (not offered for a paused role) |
| End role | Ends it for good (Permanently end). Asks a reason. An ended row is kept for audit and offers no actions |
Every option
Who can hold what
Any standard or custom study role the organization offers, except the Organization Admin; the two sponsor roles for sponsor staff; site roles only inside a site. The rules about people are on Who can and cannot; the ones you meet here are:
- One role per person per study, the same in UAT and Live (a second one: 409, or 422 team.separation_rule for a different role held in the other workspace).
- An Organization Admin holds no study role (the row is disabled; 422 team.separation_rule).
- One side of the organization: a person cannot hold both a study-team role and a site role, on any study.
- Organization members are never site staff, and site staff and sponsor staff are never organization members.
- You cannot give yourself a role carrying a permission you lack.
Who "can work"
A study-team member can work when their role is not paused. A site staff member (other than the principal investigator) can work when the investigator has signed their delegation and the delegation is in force, and the site is active. The column says why not: Waiting for the PI, Starts later, The delegation ended on …, There is no delegation on record, or the site's state.
The release gate
The first release is refused while an active production site has no Investigator (Sign off a version and go live).
What the system records
team.role_assigned, team.assignment_changed (paused, resumed, ended, with the reason), team.delegation_* events for site staff, and the mail's own status. Each assignment is attributed and dated. The person is sent You've been added to {study} as {role} and an in-app notification (Notifications).
What you cannot do, and why
- Add an Organization Admin, or the same person twice, or a person who is already site staff. These are the separation rules above.
- Add site staff here. They are added inside their site, where the investigator signs for them.
- Give someone a permission the role does not carry. Use a custom role (Manage organization roles).
- Remove an assignment without a trace. Pausing and ending need a reason and are kept.
- Have training block work. Training is recorded, not enforced (Not built yet).
Compliance Q&A
Yes. A role is granted to a named person by someone who holds team.assign, with the time; pausing and ending need a reason and are recorded; nothing is deleted. The separation rules are enforced by the application and the database.
Limits: whether the right people hold the right roles is your organization's decision; review it with the access report (Review organization access and audit).
Evidence: server/src/modules/study/team (assign-role, role-conflict)audit events team.role_assigned, team.assignment_changed
Related
Staff a site · Who can and cannot · Roles and permissions · Invite and manage members · Project Manager