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ImplementedFor site pharmacists and dispensing staff

Pharmacy

Last updated Oct 21, 2026

What this role is, and who it is for

You record dispensing and accountability, and answer the queries that come back about them, and nothing else. 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 see your own site's participants only.

Where you work

WhereScreens
OrganizationStudies, Form Library, Settings, Library form builder
The study (outside UAT and Live)Overview, Documents
BuildForms, Visit Schedule, Form builder
UAT and LiveDashboard, Forms (the design this workspace runs, read-only), Visit Schedule (read-only), Sites, Participants, Casebook, Queries, Reports: Enrollment, Reports: Site performance, Reports: Query aging, Reports: Visit compliance, Reports: Protocol deviations, Site: Queries, Site: Documents, Site: Staff, Participant: Queries
Live onlySite Team, Reports: Lock readiness

Day to day: Participants → a participant → a visit → the dispensing form, plus Queries and Documents.

Where: Live workspace > Subject > Baseline > Dispensing. Role: Pharmacy.

What you can do

  • Enter data on dispensing and accountability forms only (form.write_dispensing): the kit number pattern, the date, the quantities dispensed and returned. Your permission is deliberately narrower than a coordinator's. The system decides which forms are yours from the form's CDISC domain: a form tagged EX (exposure and dispensing) or CM (concomitant medications) is yours. If a form you should fill in is refused, the designer has not tagged its domain: ask them to set it (Design forms).
  • Answer queries about your site's data (Work with queries).
  • Read the study, your site, its participants, their visits and forms, so that you have the clinical context, the site reports, and the study documents.

Every permission this role holds

9 permissions (template version 2).

PermissionWhat it allowsHeld atRiskConstraint
document.readView, download, and preview study documentsorganization, study, sitestandard
form.readOpen forms and view answersorganization, study, sitestandard
form.write_dispensingEnter data on drug dispensing / accountability forms onlysitestandardseparation of duties (enter-vs-lock)
clinical.query.readView queriesorganization, study, sitestandard
clinical.query.answerRespond to a query on behalf of the sitesitestandardseparation of duties (query-raise-vs-answer)
site.readView site detailsorganization, study, sitestandard
study.readView study details and dashboardsorganization, study, sitestandard
subject.readView subject dataorganization, study, sitestandard
visit.readView visit schedule and dataorganization, study, sitestandard

What you cannot do, and why

  • Enter data on other forms. Vital signs, adverse events, laboratory results and the rest belong to the coordinator and the investigator. Other forms open read-only for you with a notice; a save that is tried anyway is refused by the server (403: Pharmacy may only write to dispensing forms).
  • Enroll or manage participants, or record visits.
  • Raise or close queries, or sign anything.
  • See another site's participants.

What the system does not do for you

It is not a drug-supply system. There is no inventory, no shipment tracking and no randomization or supply-system integration. What is dispensed is captured as data on a form, which is auditable, queryable and exportable like any other; the supply chain itself lives elsewhere (Not built yet).

What the system records

form.field_entered and form.field_modified for the dispensing form, query.answered. See Audit events.

Seen in the simulation

Could: enter the dispensing form (kit number pattern, date, quantities). Could not: write a clinical form (HTTP 403, Pharmacy may only write to dispensing forms (CDISC EX or CM)). In the first run the clinical form looked editable until the save and the refusal came only afterwards (F-038); it is now read-only with a notice, and the retest passed.

Where: Live workspace > Subject > Baseline > Vital signs. Role: Pharmacy.

Compliance Q&A

Compliance Q&ABuiltPart 11 11.10(g)Annex 11 12ICH E6 delegation
Is a role limited to the data entry its task needs?

Yes. The permission applies to dispensing and accountability forms only, and the server refuses a write to any other form.

Evidence: server data-capture (form.write_dispensing limited to forms tagged CDISC EX or CM)simulation of 20 Oct 2026 (403) and the retest TC-WF09-014

Enter visit data · Work with queries · Staff a site · Who can and cannot