Every routed screen requires a permission. A person needs at least one of the listed permissions on the study (and site) they are working in; a few screens are open to any signed-in user. A screen that is not in the registry is unreachable: access fails closed. The Who sees it column is worked out from the role catalog, so it cannot drift from it. Role abbreviations are on Roles and permissions.
The Organization Admin holds no study role: it reaches a study's screens only through the organization-wide permissions its role carries, and never acts on clinical data (see Who can and cannot).
Organization-level screens
| Screen | Address | Needs (any of) | Who sees it |
|---|---|---|---|
| Studies | /studies | study.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| Form Library | /library | form.read, form.design | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Roles | /rbac | rbac.manage | OA |
| Organization Team | /team | user.manage | OA |
| Access | /organization/access | rbac.manage, user.manage | OA |
| Organization Audit | /organization/audit | org.audit.read | OA |
| Settings | /settings | any signed-in user | every signed-in user |
| Organization setup (wizard) | /setup | org.manage | OA |
| Library form builder | /library/forms/*/builder | form.read, form.design | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
The study level
What is true of the study whatever its versions. Outside the three areas; no workspace.
| Screen | Address under the study | Needs (any of) | Who sees it |
|---|---|---|---|
| Overview | study | study.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| Study Versions | study/versions | study.version.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM |
| Documents | study/documents | document.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| Exports | study/exports | export.read | OA, PM, DM, SM, SSM, AUD, RM |
| Audit Trail | study/audit | audit.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM |
| Study Team | study/team | study.write, user.manage | OA, PM |
| Study Settings | study/settings | study.write | OA, PM |
Build: the design of one version
Editable while the version is in Build, read-only afterwards. A site role does not hold study.version.read, so Build is closed to it.
| Screen | Address under the study | Needs (any of) | Who sees it |
|---|---|---|---|
| Build (dashboard) | build | study.version.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM |
| Corrections | build/corrections | study.uat_issue.read | OA, PM, ED, CRA, DM, SM, AUD, PI, CRC |
| Amendment | build/amendment | study.version.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM |
| Saves | build/saves | study.version.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM |
| Forms | build/forms | form.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Visit Schedule | build/visits | visit.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Visit and Form Mapping | build/mapping | form.design, study.write | OA, PM, ED |
| AI Workstation | build/ai-workstation | ai.generate | OA, PM, ED |
| Form builder | build/forms/*/builder | form.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
UAT: the version under test
The same screens as Live, against test data; plus the screens that exist only in UAT (Issues, Results).
| Screen | Address under the study | Needs (any of) | Who sees it |
|---|---|---|---|
| Dashboard | uat | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Forms (the design this workspace runs, read-only) | uat/config/forms | form.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Visit Schedule (read-only) | uat/config/visits | visit.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Mapping (read-only) | uat/config/mapping | form.design, study.write | OA, PM, ED |
| Sites | uat/sites | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Participants | uat/subjects | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Casebook | uat/casebook | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Queries | uat/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| AE Log | uat/ae-log | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
| SAE Log | uat/sae-log | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
| SDV Plan | uat/sdv-plan | sdv.configure | OA, PM, DM |
| SDV Monitoring | uat/sdv-monitoring | sdv.perform, sdv.configure | OA, PM, CRA, DM |
| Exports | uat/exports | export.read | OA, PM, DM, SM, SSM, AUD, RM |
| Issues | uat/issues | study.uat_issue.read | OA, PM, ED, CRA, DM, SM, AUD, PI, CRC |
| Results | uat/results | study.version.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, STM, CDC, RM |
| Reports: Enrollment | uat/reports/enrollment | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Reports: Site performance | uat/reports/sites | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Reports: Query aging | uat/reports/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Reports: Visit compliance | uat/reports/compliance | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Reports: Protocol deviations | uat/reports/deviations | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| E-Signatures | uat/signatures | audit.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM |
| Audit Trail | uat/audit | audit.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM |
| Site: Queries | uat/sites/*/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Site: Documents | uat/sites/*/documents | document.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| Site: Staff | uat/sites/*/staff | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Participant: Queries | uat/subjects/*/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Participant: AEs and medications | uat/subjects/*/events | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
Live: the released version
The same screens as UAT, against production data; plus the Site Team screen and Lock readiness, which exist only in Live.
| Screen | Address under the study | Needs (any of) | Who sees it |
|---|---|---|---|
| Dashboard | live | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Forms (the design this workspace runs, read-only) | live/config/forms | form.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Visit Schedule (read-only) | live/config/visits | visit.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Mapping (read-only) | live/config/mapping | form.design, study.write | OA, PM, ED |
| Sites | live/sites | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Participants | live/subjects | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Casebook | live/casebook | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Site Team | live/site-team | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Queries | live/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| AE Log | live/ae-log | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
| SAE Log | live/sae-log | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
| SDV Plan | live/sdv-plan | sdv.configure | OA, PM, DM |
| SDV Monitoring | live/sdv-monitoring | sdv.perform, sdv.configure | OA, PM, CRA, DM |
| Exports | live/exports | export.read | OA, PM, DM, SM, SSM, AUD, RM |
| Reports: Enrollment | live/reports/enrollment | subject.read | OA, PM, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC |
| Reports: Site performance | live/reports/sites | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Reports: Query aging | live/reports/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Reports: Visit compliance | live/reports/compliance | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Reports: Protocol deviations | live/reports/deviations | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Reports: Lock readiness | live/reports/lock-readiness | study.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| E-Signatures | live/signatures | audit.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM |
| Audit Trail | live/audit | audit.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC, RM |
| Site: Queries | live/sites/*/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Site: Documents | live/sites/*/documents | document.read | OA, PM, ED, CRA, DM, MO, SM, SSM, AUD, PI, CRC, PH, STM, CDC, RM |
| Site: Staff | live/sites/*/staff | site.read | OA, PM, CRA, SM, SSM, AUD, PI, CRC, PH, STM, RM |
| Participant: Queries | live/subjects/*/queries | clinical.query.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, PH, STM, CDC |
| Participant: AEs and medications | live/subjects/*/events | clinical.event.read | OA, PM, CRA, DM, MO, SM, AUD, PI, CRC, STM, CDC |
Inside a participant
A participant has its own sidebar, in four groups that follow the work of whoever is signed in (a coordinator or investigator starts from Record, a data manager from Work, an auditor from History). A tab is listed only to a person who holds the key its page needs, so nobody is offered a screen that answers not allowed.
| Group | Tab | Needs |
|---|---|---|
| (top) | Overview | any member who can open the participant (subject.read) |
| Record | Visits & forms | any member who can open the participant (subject.read) |
| Record | AEs & medications | clinical.event.read |
| Work | Queries | any member who can open the participant (subject.read) |
| Work | Signatures | any member who can open the participant (subject.read) |
| Work | Deviations | clinical.query.read |
| Participant | Consent & eligibility | any member who can open the participant (subject.read) |
| Participant | Details | any member who can open the participant (subject.read) |
| History | Activity | any member who can open the participant (subject.read) |
| History | Reports | any member who can open the participant (subject.read) |
Two things worth knowing
Each screen is gated on what its data actually needs, not on the broadest permission that sounds related. Access is an any of these check, so listing a near-universal permission beside the real one would make the gate meaningless: Study Versions needs study.version.read rather than study.read because every role holds study.read.
E-Signatures needs audit.read, not the ability to sign. It is evidence, not an action: monitors, data managers, auditors, sponsors and project managers can read the register without being able to sign anything.
A screen a role may open is not always in that role's menu. The Who sees it column says who may open a screen. The Site Team entry of the menu is shown only to people scoped to a site; everyone else who may open it reaches a site's staff from Sites, the site, Staff.
Related
Roles and permissions · Who can and cannot · Finding your way around