Summary
This article covers the restricted permissions table and the study specific permissions table.
Table of Contents
Restricted Roles and users are those users that typically exist outside of your organization that cannot be allowed to see all data that might be displayed in a particular manager for example. These might be a CRO’s Sponsors or a Sponsor’s CROs in some cases. Restricted users do not have all the permissions available to unrestricted users, and the permissions they are granted can be further restricted using Entities and other techniques.
Restricted Permissions Table
The Restricted Roles Table contains permissions associated with access to areas of the system outside the Study Record. By default, the following permissions may be granted to Restricted Users:
| Permission | Screens Granted | Description |
|---|---|---|
| Ad-Hoc Reports | Ad-Hoc Reports | Grants access to the Ad-hoc report utilities and associated screens. Read access allows running of reports, while read/write is required to modify and create reports. |
| Collaboration Tasks | Collaboration Tasks Manager and tasks | Grants access to tasks whose workflow includes their role (both on forms and the Collaboration Manager). No Access and Read/Write only. |
| Payments | Site Payments Manager, Site Payment Approvals Manager, Payment Details, Approval Details | Grants access to both the Site Payments Manager and the Site Payment Approvals Manager, and allows access to the Details screens for the records in those tables. |
| Personnel | Personnel Manager, Edit Personnel, Personnel Documents | Grants access to the Personnel Manager and the ability to edit personnel records. |
| Reports | Standard Reports | Grants access to all Standard Reports to which the user has qualified access based on other permissions. |
| Sites | Sites Manager, Edit Site | Grants access to the Sites Manager and the ability to edit Sites. |
| Vendors | Vendors Manager, Edit Vendor | Grants access to the Vendors Manager as well as the ability to edit vendor records. |
Study Specific Permissions Table
Study Specific Permissions are associated with access to various parts of the Study Record. Restricted users may be granted any of the permissions described below:
| Permission | Screens Granted | Description |
|---|---|---|
| Action Items Collection | Action Item, Action Item Set | This permission grants access to both study and site action items, but only in a capacity that allows data entry rather than the configuration of action item sets. The user must have Site Level access to see site action items and whole study access to see study action items. |
| Action Items Configuration | Action Item, Action Item Set | Grants access to both study and site action items. It is intended for users setting up action item sets at the study or site level. The user must have Site Level access to configure site level action items and whole study access to configure study level action items. |
| Add New Site Personnel | Site Personnel | Grants the ability to add new site personnel via the Actions menu with the ‘Add New Site Personnel’ option. Existing records selected if duplicate check data matches. |
| Add New Vendor Personnel | Vendor Personnel | Grants the ability to add new vendor personnel via the Actions menu with the ‘Add New Vendor Personnel’ option. Existing records selected if duplicate check data matches. |
| Add Study | Studies | Grants the ability to add a study via the Actions menu with the ‘Add Study’ option. |
| Add Study Site | Edit Study | Grants the ability to add a site to a study via the Actions menu with the ‘Add Site to Study’ option. Existing records selected if duplicate check data matches. |
| Add Study Vendor | Edit Study | Grants the ability to add a vendor to a study via the Actions menu with the ‘Add Vendor to Study’ option. Existing records selected if duplicate check data matches. |
| Clinical Plans | Project Plan, Visit Schedule, Study Milestones, Sites Milestones, Packaging & Shipping, Monitoring Visits, Visit Plan, Data Management, Study Personnel | Clinical Plans permission grants access to all screens in the Clinical Plans sub menu within studies. |
| Create/Link Study Sites | Access to Trial Manager actions while on the Study Site Screen. | Restricted users with Read/Write permission to the Create/Link Study Sites Row shall have access to the Create Site in Trial Manager and the Link Site to Trial Manager actions on the Study Site screen for all study sites. |
| Deviations | Study Deviations, Manage Deviations | Deviations permission grants access to all screens within the Deviations sub menu in studies. This permission grants access to all Deviations for the study, it does not restrict based on sites or country restrictions. |
| Milestone Collection | Study Milestones, Site Milestones | This permission grants access to both study and site milestones, but only in a capacity that allows data entry rather than the configuration of milestones. The user must have Site Level access to see Site Milestones. |
| Milestone Configuration | Study Milestones, Site Milestones Plan, Site Milestones | Grants access to both study and site milestones, as well as the configuration screen for site milestones in Clinical Plans. Enables the user to configure and create milestones. The user must have Site Level access to see Site Milestones. |
| Monitoring Reports | Site Visits | Grants access to the Site Visits screen for each site and the ability to create and transition Monitoring Reports. |
| Regulatory Collection | Choose Regulatory Bodies, Study Regulatory Body, Edit Submission, Study Requirement Set, Study Regulatory Requirement Manager | This permission may grant users Read/Write access to the Study Requirement Set screen. All other listed screens will only be granted in Read Only mode. This disallows data entry, but users will be able to view Site Personnel documentation on the Study Regulatory Body Screen, and access the Download Documents action from the Edit Submission Screen. This permission is intended to serve data collectors for regulatory submissions. Restricted users will only have visibility of Regulatory Bodies their assigned sites are reporting to, and Submissions that have those sites listed as associated sites, or those Submissions with no associated sites. |
| Regulatory Configuration | Choose Regulatory Bodies, Study Regulatory Body, Manage Submissions, Add/Edit Submission, Study Requirement Set, Study Regulatory Requirement Manager | This permission can grant access to all actions and data entry capabilities found on the listed screens. It is intended for users setting up submissions and requirement sets. Restricted users will only have visibility of Regulatory Bodies their assigned sites are reporting to, and Submissions that have those sites listed as associated sites, or those Submissions with no associated sites. |
| Site Level | Study Site, Site Personnel, Site Feasibility Form, Site Enrollment, Site Budget, Site Contract, Patients | The Site Level permission grants access to some screens (see left) that make up the study site menu within a study. **Site Milestones, Site Visits, and Action Items require additional permissions. |
| Study Action Items | Study Action Items | This permission grants access to the Study Action Items screen. (Study Action Items will be released at a later date) |
| Study Budgets | Study Budgets | Grants access to the Study Budgets screen. |
| Study Form | Edit Study | Grants access to the ability to edit study forms. |
| Study Personnel | Study Personnel | Grants access to the Study Personnel screen in Clinical Plans. |
| Vendors | Study Vendor, Vendor Personnel, Study Vendor Contract, Study Vendor Budget | Grants access to all screens found beneath the Vendors submenu in the within a study record. |
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