What this role is, and who it is for
You are the site's day-to-day data engine. You screen and enroll participants, run their visits, enter the data and answer the questions that come back. Most of the data in the study passes through you. You are provisioned on the site by the study team and cannot work until the site's principal investigator signs your delegation of authority (Staff a site). You are a site role: you see your own site's participants and no other.
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 |
A participant's page opens at Record: visits and forms, adverse events and medications, queries and the consent and eligibility screen. Day to day you live in Participants → a participant → a visit → a form.
What you can do
- Screen, consent and enroll. Screen a participant with the consent and screening dates, record consent and re-consent, and enroll an eligible participant (Screen a participant and record eligibility, Record consent and re-consent, Enroll a participant).
- Run visits. Record how a visit was held, add an unscheduled visit, and grant early access with a reason when a visit's window has not opened yet and data must be entered now (Run a visit).
- Enter and submit form data. Submitting needs every required value; a correction to a saved value needs a query raised by someone else and a reason for change (Enter visit data, Correct data).
- Record adverse events and upgrade them to serious (Record an adverse event); record contacts with a participant.
- Answer queries raised about your site's data (Work with queries); report a protocol deviation (Report a deviation).
- Read the audit trail for your site, so you can see the full history of any value you are asked about, and the protocol, consent form and other documents published to your site.
Every permission this role holds
19 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 | |
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 | |
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) |
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 | |
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
- Make the eligibility determination. It is an investigator attestation: you prepare everything and the investigator decides. The consent and eligibility screen has no Mark eligible control for you.
- Complete, withdraw or declare lost to follow-up a participant. Those are the investigator's (or an Organization Admin's) acts.
- Apply the investigator signature, or sign a delegation.
- Close a query, even one you answered, or raise one. The site answers; an independent person (the Data Manager, the Clinical Data Coordinator or the Medical Officer) closes.
- Change a signed and locked form. The change is refused with a message; it can be done only through the controlled path.
- See another site's participants, start exports, or change the study design.
What the system records
subject.screened, subject.enrolled, subject.reconsented, form.field_entered, form.field_modified (with the reason), subject.visit_early_access_granted, subject.unscheduled_visit, query.answered, event.recorded, deviation.reported. See Audit events.
Seen in the simulation
Could: screen participants, enter and submit forms, enroll an eligible participant, record adverse events and upgrade them to serious, report deviations, record re-consent, answer queries. Could not: record eligibility (only the investigator); close a query it answered; change a locked form; see another site's participants.
Compliance Q&A
Yes. Every value entered and every change is an audit event with the person, the time, the earlier and the new value and the reason.
Evidence: server data-capture (field-level audit events with reason for changea saved value changes only through a query raised by someone else)simulation of 20 Oct 2026, steps 5 and 6
Related
Enter visit data · Correct data · Work with queries · Principal Investigator · Who can and cannot