All roles
PM
Project Manager guidePer study42 permissions
Project Manager
Runs study execution — staffs the team, creates sites, tracks quality; can raise queries.
What this role can do
- Raise data queries
- Decide which fields require source verification
- Sign off a version for release
- Design case report forms
- Configure studies
- Report protocol deviations
- Set the safety report status of a serious event
- Upload and version study documents
Boundaries (segregation of duties)
- Cannot enter or correct clinical data
- Cannot answer a query it raised (separation of duties)
- Cannot perform source verification — only plan it
Exact permissions
The real permissions this role carries, taken from the platform’s own catalogue. Holding a permission is necessary but not sufficient — access is further narrowed by study membership, site, and whether the study’s data is test or live.
Studies
study.readView study details and dashboardsstudy.writeEdit study settings and teamsstudy.state.changeHold, resume, close to enrollment and complete a studystudy.lockLock and unlock the study database (two different people, each with an e-signature)
Versioning
study.version.readView the study's versions: the version list, UAT cycles, sign-offs and the changes between versionsstudy.amendment.startStart an amendment (the next version of a Live study)study.version.submit_uatSubmit a version in Build to UAT (freezes its design and opens a UAT cycle)study.uat.close_cyclePass or fail the open UAT cycle (a failed cycle returns the version to Build)study.uat_issue.readView the issues and results of a UAT cycle (what testers found, and what became of it)study.uat_issue.writeRaise, edit, resolve, accept and reopen the issues of the open UAT cyclestudy.version.signoffSign off a version that passed UAT (author, QA or approver; three different people)study.version.go_liveTake an approved version Live (supersedes the version that was Live)study.version.withdrawWithdraw a version that has not gone Live
Sites
site.readView site detailssite.writeCreate / edit sites and staffsite.activateActivate a registered sitesite.transitionTransition site lifecycle (suspend / resume / close)
Subjects
subject.readView subject data
Safety
clinical.event.readRead a subject’s events and the adverse event and SAE logsclinical.event.reportSet the safety report status of a serious adverse event and its awareness timeclinical.event.reconcileRecord the reconciliation of a serious adverse event with the safety databasedeviation.reportReport and update protocol deviation status
Visits
visit.readView visit schedule and data
Forms
form.readOpen forms and view answersform.designEdit form templates in builderform.publishPublish form versions to liveform.freezeMarks a role as data-locking authority (separation of duties: cannot also enter data)
Workflow
workflow.designBuild and edit workflows
Queries
clinical.query.readView queriesclinical.query.raiseOpen a new manual query
Monitoring
sdv.configureDefine the SDV / risk-based targeting plan (which fields require source verification)
Audit
audit.readAccess audit trail
Exports
export.readView export historyexport.runTrigger ad-hoc and signed exports
Team
team.assignAssign / provision a study team roleteam.manageSuspend / resume / retire team assignmentsteam.training_completeMark a team member as protocol-training complete
AI
ai.generateGenerate or edit forms with AI
Admin
user.directory.readBrowse the organization user directory (for team staffing)
Documents
document.readView, download, and preview study documentsdocument.writeUpload documents, add versions, edit metadatadocument.manageApprove and archive study documents
Continue reading