Project Manager

What this role is, and who it is for#

You run the study. You staff it, you open its sites, you move it through its states, you take its versions through UAT to Live, and you are the author leg of the three-way release sign-off. You are named when the study is created, by the Organization Admin, so a study never exists without someone to run it (Create a study). Nobody has to give you a breakpoint to staff the team: you add any study or site role, and only a role that would give you more than you hold yourself is compared (Who can and cannot).

Where you work#

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What you can do#

Design and versions

• Build forms, the visit schedule, the mapping and the rules alongside the designer, and use the AI form generator (Build a study, Design forms).
• Submit a version to UAT, close a UAT cycle as passed or failed, raise and read UAT issues, take a passed and approved version Live by typing its version number, withdraw a version and start an amendment (Test a version in UAT, Sign off a version and go live, Amend a live study).
• Apply the author sign-off with a fresh code. The capacity comes from your role; you cannot choose it, and you cannot also sign as QA or approver.

People and sites

• Staff the study team from the organization and add sponsor staff; mark protocol training complete; suspend or retire assignments (Staff a study team).
• Register sites, activate them through the ethics gate, suspend, reinstate and close them, provision site staff and propose their delegations (Open a site, Staff a site). The principal investigator, not you, signs a delegation.

The study's state

• Put the study on hold, resume it, close it to enrollment, complete it, and request a database lock or unlock with an e-signature; a different person confirms (Change the state of a study, Close and lock a study).

Quality and oversight

• Raise queries; report adverse events and deviations and move deviations through review; reconcile a serious adverse event with the safety database; define the SDV plan (Work with queries, Report a deviation, Review and reconcile a serious adverse event, Monitor and verify data).
• Run and download exports; upload, version, approve and archive study documents; read the audit trail, the reports and the dashboard (Export data, Manage documents, Use the reports and the dashboard).

Every permission this role holds#

42 permissions (template version 7).

What you cannot do, and why#

• Create a study or archive one. Creating and archiving are the Organization Admin's.
• Enter or correct clinical data. You can read every form, not write a value.
• Answer, close or reopen queries. You raise them; the site answers and an independent reviewer closes.
• Verify data against source. That is the monitor's job, and the person who entered a value never verifies it.
• Apply an investigator signature or sign a delegation. Only the principal investigator can: nobody signs their own entry.
• Confirm a lock or an unlock you requested. Two different people lock and unlock the database.
• Sign as QA or approver. Three different people sign a version.
• Add an Organization Admin to the team, give anyone a second role on the study, or add an organization member to a site team. The rules are on Who can and cannot.

What the system records#

study.version.* (submitted, signed off, went live, withdrawn), study.amendment.started, study.state.changed, study.lock.initiated, team.role_assigned, team.assignment_changed, team.delegation_proposed, site.registered, site.activated, site.transitioned, sdv.plan_updated, query.raised, deviation.status_changed, event.reconciliation_recorded, export.*, document.*. See Audit events.

Seen in the simulation#

Could: staff the study team from the organization; register and activate sites (in UAT and in Live), provision site staff and propose delegations; submit to UAT, pass or fail UAT cycles, sign as author, take a version Live; start an amendment; set the SDV plan; move deviations through review; put the study on hold, close it to enrollment, complete it; request a lock and an unlock and withdraw a request. Could not: sign a delegation; confirm a lock or unlock the same person requested; archive; add an Organization Admin, add a second role to the same person, or add an organization member as external staff. Roles other than the build team's (Clinical Research Associate, Medical Officer and so on) were accepted on a study in Setup.

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Compliance Q&A#

Related#

Create a study · Staff a study team · Review and release a study · Open a site · Close and lock a study · Who can and cannot