What this role is, and who it is for
You are the investigator of record. You decide eligibility, you authorize your site staff, and you are the only person who applies the investigator signature. You hold the same data-entry permissions as your coordinator, so you can enter and correct data yourself, but most days you review rather than type. The role is held at one site; you are given it when the site is registered and its investigator is named (Open a site).
Where you work
| Where | Screens |
|---|---|
| Organization | Studies, Form Library, Settings, Library form builder |
| The study (outside UAT and Live) | Overview, Documents, Audit Trail |
| Build | Corrections, Forms, Visit Schedule, Form builder |
| UAT and Live | Dashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Sites, Participants, Casebook, Queries, AE Log, SAE Log, Reports: Enrollment, Reports: Site performance, Reports: Query aging, Reports: Visit compliance, Reports: Protocol deviations, E-Signatures, Audit Trail, Site: Queries, Site: Documents, Site: Staff, Participant: Queries, Participant: AEs and medications |
| UAT only | Issues |
| Live only | Site Team, Reports: Lock readiness |
You see only your own site's participants. A participant's page opens at Record (visits and forms, adverse events and medications, queries, signatures, consent and eligibility) with the other groups beside it.
What only you can do
- Determine eligibility. No other role holds
subject.eligibility. A participant cannot be enrolled until you have recorded them eligible; recording them ineligible screen-fails them in the same act, attributed to you (Screen a participant and record eligibility). - Sign your site staff's delegation of authority. A coordinator or pharmacist added to your site has no access at all until you e-sign their delegation with a fresh code, your typed name and the confirmation of their training. The study team provisions them; you authorize them. You cannot authorize your own appointment (Staff a site).
- Apply the investigator signature to a record. Signing seals it; a later authorized change withdraws the signature (Sign records).
- Complete, withdraw or declare lost to follow-up a participant, with the facts the protocol needs (
subject.delete, shared with the Organization Admin: Change a participant's status).
- Only the principal investigator can sign a delegation.
What else you can do
- Enter and correct data, run visits, add unscheduled visits and grant early access to a visit (Run a visit, Enter visit data, Correct data).
- Screen, consent and enroll participants; record consent and re-consent (Enroll a participant, Record consent and re-consent).
- Record adverse events, upgrade them to serious, record follow-ups and mark reports sent (Record an adverse event, Review and reconcile a serious adverse event).
- Answer queries raised about your site's data (Work with queries); report protocol deviations (Report a deviation).
- Read the audit trail for the data you sign, so you can see every change, who made it and why, before you attest to it.
- Take part in UAT by reading and raising issues against the design (Test a version in UAT).
Every permission this role holds
24 permissions (template version 6).
| 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 | |
signature.sign | Apply e-signatures to records | site | critical | investigators only; needs an e-signature |
form.read | Open forms and view answers | organization, study, site | standard | |
form.write | Enter / edit form data | site | standard | separation of duties (enter-vs-lock) |
clinical.query.read | View queries | organization, study, site | standard | |
clinical.query.answer | Respond to a query on behalf of the site | site | standard | separation of duties (query-raise-vs-answer) |
clinical.event.read | Read a subject’s events and the adverse event and SAE logs | organization, study, site | standard | |
deviation.report | Report and update protocol deviation status | organization, study, site | standard | |
clinical.event.write | Record, upgrade to serious, and remove an event (adverse event, concomitant medication) | site | standard | |
clinical.event.report | Set the safety report status of a serious adverse event and its awareness time | organization, study, site | standard | |
site.read | View site details | organization, study, site | standard | |
study.read | View study details and dashboards | organization, study, site | standard | |
subject.read | View subject data | organization, study, site | standard | |
subject.write | Enroll subjects, edit data | site | standard | separation of duties (enter-vs-lock) |
subject.delete | Withdraw / archive subjects | organization, study, site | elevated | |
clinical.contact.write | Record, and remove with a reason, a contact with a subject | site | standard | |
clinical.consent.write | Record a subject's consent, or refusal, when an amendment asks them to consent again | site | standard | |
subject.eligibility | Determine subject eligibility (investigator attestation) | organization, study, site | critical | investigators only |
delegation.sign | Sign the delegation-of-authority for a site assignment | organization, study, site | critical | investigators only; needs an e-signature |
study.uat_issue.read | View the issues and results of a UAT cycle (what testers found, and what became of it) | organization, study, site | standard | |
study.uat_issue.write | Raise, edit, resolve, accept and reopen the issues of the open UAT cycle | organization, study, site | standard | |
visit.read | View visit schedule and data | organization, study, site | standard | |
visit.write | Visit-schedule participation (visit-instance edits are gated by subject.write) | site | standard |
What you cannot do, and why
- Raise queries. You answer them. The system does not let one role both raise and answer.
- Close queries. An independent reviewer does.
- See another site's participants, or change the study design.
- Start exports. You hold no export permission.
- Change a signed form without the controlled path. A signed record can change only through a query raised by someone else and a reason, and the change withdraws your signature.
Signing, in practice
Signing asks for a fresh six-digit code emailed to you, every time, even though you are signed in. The code works only for signing and only for the record you requested it for. The system stores what you signed as a fingerprint, so if the data is ever changed the signature is flagged rather than quietly carried forward. The signature records what it meant, your name and the time (Sign records).
What the system records
subject.eligibility_determined, team.delegation_signed, signature.applied, signature.superseded, auth.stepup.verified, subject.transitioned, form.field_entered, form.field_modified, query.answered, event.recorded, deviation.reported. See Audit events.
Seen in the simulation
Could: sign delegations of authority (fresh code, typed name, training confirmation); confirm eligible or ineligible; sign and lock a form; move a participant to Active, Completed, Withdrawn or Lost to follow-up; record serious adverse event follow-ups and mark reports sent. Could not: start exports; change a locked form without the controlled path.
Compliance Q&A
Yes. Only an investigator role can hold the three permissions; no custom role can be given them without being an investigator role; and nobody signs their own delegation.
Evidence: role-catalog pi (subject.eligibility, delegation.sign and signature.sign are investigator-only, enforced in the role editor and the server)simulation of 20 Oct 2026 (delegations signed with step-up codeseligibility denied to the coordinator and the Project Manager)
Related
Screen a participant and record eligibility · Sign records · Staff a site · Work with queries · Clinical Research Coordinator