What this role is, and who it is for
You own the study's document register and the exports that go with a submission. The role is built around documents and evidence, not around the clinical record: you hold no permission to read participants, visits, forms or queries on screen. You are given the role on a study's team by the Project Manager (Staff a study team).
Where you work
| Where | Screens |
|---|---|
| Organization | Studies, Settings |
| The study (outside UAT and Live) | Overview, Study Versions, Documents, Exports, Audit Trail |
| Build | Build (dashboard), Amendment, Saves |
| UAT and Live | Sites, Exports, Reports: Site performance, Reports: Visit compliance, E-Signatures, Audit Trail, Site: Documents, Site: Staff |
| UAT only | Results |
| Live only | Site Team, Reports: Lock readiness |
- Only what the role may open is listed.
What you can do
- Upload documents, add versions, edit their details, approve and archive them: protocol versions, amendments, the investigator's brochure, consent forms and regulatory correspondence (Manage documents).
- Run and download exports (Export data).
- Read the study, its sites and versions, and the study-level audit trail and e-signature register.
Every permission this role holds
9 permissions (template version 2).
| Permission | What it allows | Held at | Risk | Constraint |
|---|---|---|---|---|
audit.read | Access audit trail | organization, study, site | standard | |
document.read | View, download, and preview study documents | organization, study, site | standard | |
document.write | Upload documents, add versions, edit metadata | organization, study | standard | |
document.manage | Approve and archive study documents | organization, study | standard | |
export.read | View export history | organization, study | standard | |
export.run | Trigger ad-hoc and signed exports | organization, study | critical | |
site.read | View site details | organization, study, site | standard | |
study.read | View study details and dashboards | organization, study, site | standard | |
study.version.read | View the study's versions: the version list, UAT cycles, sign-offs and the changes between versions | organization, study | standard |
What you cannot do, and why
- Read participants, visits, forms or queries on screen. You hold none of the read permissions for them.
- Change the design or the study's state, or sign anything.
An exception you should know about
A data export is gated by export.run alone. Its events, queries and audit trail parts are included only if you may read them; its participants and status and form data parts are not gated by the read permissions. So you can export the participants and form data of the whole study although you cannot open them on screen. An organization's decision to give someone export.run is therefore a decision about access to the data (Export data).
What the document register is, and is not
Each document is an entry in the register with a type, title, version and status (draft, approved, archived). The file goes straight to secure object storage; each version is kept, and replacing a document adds a version rather than overwriting. A document can be attached to the study as a whole or to a site. Documents registered in UAT are test documents. It is a register, not an eTMF: no TMF reference model, expected-document checklist or completeness scoring (Documents reference).
What the system records
document.uploaded, document.version_added, document.metadata_updated, document.approved, document.archived, document.downloaded, export.requested, export.completed, export.downloaded. See Audit events.
Seen in the simulation
Could: start an export. Not tried: document upload beyond the protocol (done by the Project Manager).
Compliance Q&A
Yes. A document keeps every version, with its checksum and the person who added it; approval and archiving are recorded with the person and the time.
Limits: it is a register, not a trial master file.
Evidence: server documents (versions added, never overwrittenapprovalaudit events document.*)
Partly. A role without the permission to read participants can still produce an export that contains them, because export.run is the only gate on those two parts.
Limits: the events, queries and audit-trail parts of an export follow the reader's permissions, and a person confined to sites exports only those sites. Participants and form data do not follow subject.read. Until that is changed, treat export.run as access to the data.
Evidence: server exports (export.run gates the requestevents, queries and audit parts check the reader's rightsparticipants and form data parts do not)
Related
Manage documents · Export data · Documents reference · Exports reference