MyRBQM Privileges
Below are a list of all of the Privileges (and their descriptions) in the MyRBQM Portal. Please note the following three rules that apply regarding the Pivileges:
- If a company doesn't use the Privilege - Role functionality, all Privileges will be allowed to its users. Company Administrator type of access is not default.
- If the entire content of a page is affected by a Privilege and the User does not have that Privilege, they will be redirected to an error page (noted in privilege description if applicable).
- If the user does not see one of the privileges below in their instance of MyRBQM, it means that they have not been assigned that privilege. If the user disagrees with this, they will need to contact their Company Administrator of the MyRBQM Portal.
| Privilege | Function |
|---|---|
| Accept Risks & Create Mitigations | Access the course of action for a Risk section: Accept Risks Create Mitigation Actions (including Suggestions and Ask AI) Edit the Risk’s Acceptance Rationale |
| Access Audit Logs | Access Study Audit Trial and Company Audit Trial |
| Access Data Import Logs | Access Study Settings hub View Recent Tasks page (Latest imports, Latest data processing tasks) |
| Access Database Logs | Access Study Settings hub View Task Logs page |
| Assign & Edit Investigative Actions | Create, edit, activate, review, close and delete Investigative/Corrective Actions ("View Tickets" privilege is required to access Tickets page) |
| Assign & Edit Preventive Actions | Create, edit, activate, review, close and delete Preventive Actions (To close: ticket should be active, Root Cause Analysis should be started) ("View Tickets" privilege is required to access Tickets page) ("Assign & Edit Tickets" privilege is required to access Preventive Actions section) |
| Assign & Edit Tickets | Activate, assign, re-assign, close Tickets Start and re-start (only for Active tickets), finish Root Cause Analysis Add, edit, remove root causes ("View Tickets" privilege is required to access Tickets page) |
| [pending] CDQ - Access Compliance and Data Quality Check | [pending] |
| [pending] CDQ - Status Change | [pending] |
| Company Administrator |
All existing privileges are included in CA privilege by default. In addition CA privilege gives rights to:
Manage Company Settings (including Invite, edit, block users, give Company Admin right, set user Session Time-out, configure SSO, access company integration API, Set Actions Review Settings Company LevelSet Investigative/Corrective Actions Closure settings at Company Level)
See Retired Sites
Manage Study Settings (including Set Study to Non-Live, Delete Study Data, Delete Pending Tasks, Manage Data Processing, Upload/download Additional Study Protocol Data and Study Data)
Set Default Root Causes for Root Cause Analysis on a study level Cancel processing, delete, archive CSM Requests create by another user |
| Create CSM-related Tickets | Create a ticket from the CSM Request Results page and Request Summary page ("View CSM" privilege is required to access CSM requests page) |
| Create Generic Tickets | Create a ticket from the Tickets page ("View Tickets" privilege is required to access Tickets page) |
| Create KRI-related Tickets | Create a ticket from the Risk Indicator page ("View KRIs" privilege is required to access KRIs page) |
| Create QTL-related Tickets | Create a ticket from the QTL page ("View QTLs" privilege is required to access QTLs page) |
| Create Site-related Tickets | Create a ticket from the Site Details page ("View Sites" privilege is required to access Sites page) |
| Create Subject Profile-related Tickets | Create a ticket from the Subject Profile page ("View Subject Profiles Dashboard" privilege is required to access Subjects page) |
| Define Company Roles | Access Configuration hub (Company Settings) Access Roles page Create, edit, delete, import and export Roles, set a default role |
| Download IQRMP Reports | Download IQRMP Report from the Risk Management Overview page |
| Edit & Activate Mitigations | Edit, activate and delete (to delete, status should be "New") Mitigation Actions |
| Edit & Add Report Templates | Create, edit and delete Datasource templates on the Datasource page Create, edit and delete Reports on the Reports page ("View Reports" privilege is required to access Reports and Data Sources pages) |
| Edit Automatic Ticket Assignment | Access Ticketing System Configuration from the Tickets page Configure default designees for new tickets on different levels ("View Tickets" privilege is required to access Tickets page) |
| Edit QTL Configuration | Access Configure QTLs page in the Study Settings hub Manage settings in Configure QTLs page |
| Edit RACT Drafts | Edit RACT Working Draft (including Edit Risks) |
| Edit Study Details | Edit Study Details on the Study Details page |
| Generate AI Critical Processes and Data | Generate Study Critical Processes and Data on the AI-Enhanced Protocol Analysis tool page AI-Generated Study Critical Processes and Data: view, edit, delete, download |
| Generate AI Risk Assessment | Generate Risk Assessment on the AI-Enhanced Protocol Analysis tool page AI-Generated Risk Assessment: view, edit, delete |
| Import/Export Configuration Variables | Import or export KRI/QTL Values on the Import/Export Config page in the Study Settings hub |
| KRI Linkage to Risks | Add and remove an Associated Risk Indicator on the Risks Overview Page Edit Likelihood of a Risk if KRI fires |
| KRI Threshold Changes | Access Configure page in the Study Settings hub Manage settings in Configure page |
| Manage Action Settings | Access Actions Settings page in the Study Settings hub Set Actions Review Settings at Study level Set Investigative-Corrective Actions Closure settings at Study Level Choose to use Company-level settings for a study |
| Manage CSM | Create CSM request Edit, send for processing any CSM request Cancel processing, Delete, Archive only created by me CSM Requests ("View CSM" privilege is required to access CSM requests page) |
| Manage Catalogs | Create, import, edit, edit details, copy and delete Catalogs ("View Catalogs" privilege is required to access Catalogs page) |
| Manage Critical Processes and Data | Access Company Critical Processes and Data Edit, delete, import, mark as critical Study Critical Processes and Data on the Study Details page and Company Critical Processes and Data |
| Manage Custom Calculations | Create, monitor and manage customer-provided metrics, KRIs and QTLs ("View Metrics", "View KRIs" and "View QTLs" privileges are required to access relevant pages) |
| Manage Groups | Access User Groups page in the Study Settings hub Create, edit and delete User Groups |
| Manage Risks | Edit risk name (a short risk identifier e.g. RISK_XXX) |
| Manage Study Protocol | Upload and clear Study Protocol Data Change Vital Timelines Change Target Number of Patients Enable Subject Profile module ("View Study Protocol" privilege is required to access Study Protocol page in the Study Settings hub) |
| [pending] Manage Study Type Templates (Study Wizard) | [pending] |
| Manual Study Data Upload | Upload study data via browser (one or multiple files) on the Study Data page in the Study Settings hub |
| Release RACT Drafts | Release RACT Working Draft |
| Retire Studies | Retire Studies |
| Review & Close Mitigations | Review, Close, Promote active Mitigation Actions |
| Review & Sign Subject Profiles | Leave a Review for a Subject ("View Subject Profiles Dashboard" privilege is required to access Subjects page) |
| Save CSM Request Study Data for Download | Set up creation of .csv file with the Study Data that was fetched to a CSM Request (When creating a new CSM Request, a setting "Save Study Data for Download" is available. If selected, any User with access to the CSM Request will be able to download study data that was fetched to a CSM Request) ("View CSM" privilege is required to access CSM requests page) ("Manage CSM" privilege is required to create CSM requests) |
| Set up Studies | Create New Study on the Studies List page Access Studies Wizard page |
| Set up Study Access & Visibility | Access Configuration hub (Company Settings) Access Study Access page Assign existing studies to users |
| Unretire Studies | Unretire Study on the Study card |
| View CSM | Access Centralized Statistical Monitoring page Access CSM Request Details, CSM Request Results and CSM Request Summary pages Download data files from CSM Requests |
| View Catalogs | Access Catalogs List page Access Catalog details page Export Catalogs |
| View KRI Wiki | Access KRI Wiki in the Help dropdown |
| View KRIs | Access KRI page Access Risk Indicator Details page |
| View Metrics | Access Metrics page Access Metric Details page |
| View QTLs | Access QTL page Access QTL Details page |
| View Reports | Access Datasources and Reports pages View and download a Datasource template View and print a Report |
| View Retired Studies | Filter Retired studies on the Studies List page View Retired studies cards |
| View Retired Studies Data | View Retired Study Data in Read-Only Mode ("View Retired Studies" privilege is required to access retired studies on the Studies List page) |
| View Sites | Access Sites page Access Site Details page |
| View Study Dashboard | Access Dashboard page |
| View Study Protocol | Access Study Protocol page in the Study Settings hub |
| View Subject Profiles Dashboard | Access Subjects page Access Subject Profile page Access Subject Profile reviews |
| View Tickets | Access Tickets page Access Ticket Details page Subscribe to or unsubscribe from a ticket |
| View User Management | Access Configuration hub (Company Settings) View User Management page |
Functionality available to all users in MyRBQM independently from any privilege:
- Access Studies List page
- View non retired Studies tiles on the Studies list page
- Download Studies Overview Report
- View Risks Mind Map
- Access Study Details page
- View Study Details
- View Study Critical Processes and Data
- Access Risk Management Overview page
- View RACT Working Draft and previous releases
- Export study
- Access Risk Overview Page
- View Study Risks
- Access Actions List page
- View list of Mitigation, Investigative/Corrective and Preventive Actions
- Access Mitigation Details page
- Access AI-Enhanced Protocol Analysis Tool page
- Access Protocol Complexity Assessment
- Access Study Settings hub in read-only mode
- Access Study Data page from Study Settings hub
- Access Technical Config page from Study Settings hub
- Download data
- Access Notifications List page
- Access My Account
- Update information and notification preferences in My Account