Summary
This article covers the unrestricted permission table and the study specific permissions table.
Table of Contents
Unrestricted Roles and users are those users in your organization that do not have restrictions on what records they are allowed to see on a given screen. These are likely to be users that are internal to your organization and we are simply concerned, in this case, with the screens the user has access to.
Unrestricted Permissions Table
The Unrestricted 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 Unrestricted 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. |
| Alerts | Alerts Manager | Grants access to the Alerts Manager screen. |
| Audits | Question Audits Manager, Form Audits Manager, Transition Audits manager | Grants access to all Audits Managers. |
| Collaboration Management | Collaboration Manager | Grants access to view all tasks in the Collaboration Manager as well as the ability to create tasks. No Access and Read/Write only. |
| Collaboration Tasks | Collaboration Manager | Grants ability to create tasks and access to the Collaboration Manager to view only tasks visible to user through workflow assignment. No Access and Read/Write only. |
| Communications | Communications Manager, Group Manager | Grants access to the Communications Manager and related subscreens. The Read/Write permission grants access to all actions on the Communications Manager Screen and the Group Manager Screen, and the actions “Send Communication” and “Assign to Communication Group” in the Personnel Manager. |
| Imports | Imports Manager | Grants access to the Imports Manager and the ability to import data into the system. |
| Milestones | Milestones Manager, Study Milestones, Site Milestones Configuration, Site Specific Milestones | Grants access to both the Milestones Manager, and all screens associated with milestones at the study level. The user must have Study Form access along with Milestones access to see the Milestone screens. |
| Monitoring Configuration | Define Monitoring Templates | Grants the user access to the Define Monitoring Templates screen from the Dashboard and controls the ability to add and modify those templates. |
| 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, Add/Edit Personnel, Personnel Documents | Grants access to the Personnel Manager and the ability to add and edit personnel records. |
| Products | Products Manager, Add/Edit Products | Grants access to the Products Manager and the ability to add and edit product records. |
| Regulatory | Regulatory Requirements Manager, Regulatory Bodies Manager, Add/Edit Regulatory Bodies, Add/Edit Regulatory Categories, Add/Edit Standard Requirement Sets | Grants access to the Regulatory Requirements Manager and the Regulatory Bodies Manager, as well as all screens associated with adding and editing Regulatory Bodies, Regulatory Categories, and Standard Requirement Sets. |
| Reports | Standard Reports | Grants access to all Standard Reports to which the user has qualified access based on other permissions. |
| Sites | Sites Manager, Add/Edit Site | Grants access to the Sites Manager and the ability to Add/Edit Sites. |
| User Administration | User Admin | Grants access to the user administration screens from the Study Homepage, and the ability to add/edit user permissions. |
| Vendors | Vendors Manager, Add/Edit Vendor | Grants access to the Vendors Manager as well as the ability to add or edit vendor records. |
Study Specific Permissions Table
Study Specific Permissions are associated with access to various parts of the Study Record. Unrestricted 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. |
| 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. |
| 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. | Unrestricted 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. |
| 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. |
| 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. |
| 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 | Add/Edit Study | Grants access to the ability to add and 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 sub-menu within a study record. |
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