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Principal Investigator

Site investigator-of-record — enters/verifies data, answers queries, applies the investigator e-signature.

Principal Investigator guide

What this role can do

  • Enter and correct clinical data
  • Screen, enroll, and manage participants
  • Determine participant eligibility
  • Withdraw a participant, with a reason
  • Answer queries on behalf of the site
  • Apply electronic signatures
  • Authorize site staff by signing their delegation
  • Report protocol deviations

Boundaries (segregation of duties)

  • Cannot raise queries — answers only
  • Cannot close a query it answered — an independent role closes
  • Cannot change the study or its form design
  • Confined to its own site's participants

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 dashboards

Sites

  • site.readView site details

Subjects

  • subject.readView subject data
  • subject.writeEnroll subjects, edit data
  • subject.deleteWithdraw / archive subjects
  • clinical.contact.writeRecord, and remove with a reason, a contact with a subject
  • clinical.consent.writeRecord a subject's consent, or refusal, when an amendment asks them to consent again
  • subject.eligibilityDetermine subject eligibility (investigator attestation)

Safety

  • clinical.event.readRead a subject’s events and the adverse event and SAE logs
  • deviation.reportReport and update protocol deviation status
  • clinical.event.writeRecord, upgrade to serious, and remove an event (adverse event, concomitant medication)
  • clinical.event.reportSet the safety report status of a serious adverse event and its awareness time

Visits

  • visit.readView visit schedule and data
  • visit.writeVisit-schedule participation (visit-instance edits are gated by subject.write)

Forms

  • form.readOpen forms and view answers
  • form.writeEnter / edit form data

Queries

  • clinical.query.readView queries
  • clinical.query.answerRespond to a query on behalf of the site

E-Sign

  • signature.signApply e-signatures to records

Team

  • delegation.signSign the delegation-of-authority for a site assignment

Versioning

  • 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 cycle

Audit

  • audit.readAccess audit trail

Documents

  • document.readView, download, and preview study documents

Continue reading

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