Staff a site

What this is, and who it is for#

The people who work at a site (the coordinators, the pharmacist, sub-investigators) are site staff. They are not on your Organization Team and not on the study team: they are created for the site. The system separates two acts on purpose: the study team provisions a person at a site, and only the site's principal investigator authorizes them by signing their delegation of authority. Until that signature the person has no access to participant data.

Held by: Organization Admin, Project Manager (team.assign).

Held by: Principal Investigator (delegation.sign).

Where to find it#

Inside a workspace (UAT or Live): Sites → the site → Staff; or Site Team in the workspace menu, which is My Site (Your site's delegation log) for site staff and shows their own site; anyone else who opens it is told No site is assigned to you yet, and uses Sites → the site → Staff. The Staff panel lists the site's people with Person, Role, Delegation, Training and Added; the principal investigator is marked PI of record. Choosing a person shows their delegation log.

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1. The site's own staff, with the principal investigator marked PI of record.
2. Each person's delegation: in force once the principal investigator has signed an entry.
3. A new entry for this person; it takes effect when the principal investigator signs it.

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1. Opens the site's staff.

What you can do#

Provision a person#

1. On the site's Staff panel choose Provision staff (or Provision staff in an empty site: No site staff yet).
2. In Provision site staff (Add a person to {site}): choose the Site role, type the person's Name and Email (a valid address is required).
3. The dialog says what happens: a site-scoped account (organization-owned) is created for them. They don't join the Organization Team, and a member of the Organization Team is never site staff. The new person is Pending delegation.
4. Choose Provision. The person is e-mailed You've been added to {study} as {role} with the site named; a site role other than the investigator takes effect once the investigator has signed the delegation.

A Principal Investigator signs for themselves, so there is no delegation to wait for; the investigator named when the site was registered is already in place.

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1. Adds a person to the site; access begins only when the principal investigator signs.

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Sign a delegation (principal investigator)#

1. The PI sees Sign as PI next to the person's entry (nobody else does, and nobody signs their own entry).
2. Sign delegation of authority shows You are delegating the tasks of the role, with Training & qualification confirmed: I confirm this person is trained and qualified for the delegated role, and I delegate these trial-related duties to them. Tick it. This is your confirmation in the log; the Training column on the Staff page is a separate flag.
3. Take the fresh one-time code the system sends you and type your name. The signature is an e-signature.
4. A toast says Delegation signed — {name} is now active at {site}. The person can work from the entry's start date.

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1. Opens the signing dialog.

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Keep the delegation log#

Each person has a log of entries: Entry, Delegated tasks, Dates, Status and People (who proposed and who signed). Access follows the log: access to participant data begins only when the principal investigator has signed an entry.

• Propose amendment (offered when no entry is waiting for a signature): choose the tasks this person may do (from those the role can be delegated), Starts on (today or later) and Ends on (optional; the first day it no longer applies). Amendment proposed — it takes effect when the PI signs it. An amendment is a new entry; signing it ends the one in force.
• Withdraw a proposal that is waiting.
• End entry with a reason (Why this entry ends.) to end the one in force.
• A role that delegates nothing is shown Nothing gated — reading only.

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1. Choosing a person shows their delegation log.

Pause, resume, end, training#

From the study's team screens (Staff a study team): Pause role, Resume role, End role (each with a reason) and Mark training complete. Training is recorded and blocks nothing.

Every option#

Who can work#

A site person can work when: their role is not paused; the site is active; and their delegation is in force (signed, started, not ended). The Delegation column says why not: Waiting for the PI, Starts later, The delegation ended on … or There is no delegation on record. An investigator needs no delegation (Investigator of record. No delegation needed.).

Rules about people at a site#

• A person holds one role at one site per study (on another study they can be somewhere else).
• A person is never both study-team and site staff, on any study.
• An organization member cannot be site staff; site staff are never organization members.
• The person who provisions cannot be the one who authorizes: only the investigator signs.

What the system records#

team.role_assigned, team.delegation_proposed, team.delegation_signed (the signer, the time, the tasks and the one-time-code check), team.delegation_ended, team.assignment_changed, team.site_team_ended and the mail. See Audit events.

What you cannot do, and why#

• Give a person access without the investigator's signature. The delegation is the authority.
• Sign your own delegation, or sign as a role that is not the investigator.
• Put an Organization Admin or organization member on a site's staff.
• Delete a delegation. Entries are ended, and kept.
• Have training gate work. It does not.

Compliance Q&A#

Related#

Open a site · Staff a study team · Principal Investigator · Who can and cannot