After the study roles have been configured, this template can be used to set permissions for common roles in clinical research.
Important Note: This template is merely a guide to assist in setting up common user permissions. Always be sure to review and test roles before moving a study live.
Study role permissions cannot be enabled or disabled on iOSThe user roles in this template are defined as follows:
- Administrator - Responsible for the study build and overall control.
- Data Manager - Responsible for study-wide data management after the study has been built and deployed to sites for data collection.
| Application | Permissions | Administrator | Data Manager | Monitor | Principal Investigator | Data Coordinator |
| Access Study Related Forms | Grant Access | X | X | X | X | |
| Action Item Report | Grant Access | X | X | X | X | X |
| Coordinator Action Items | X | X | X | X | ||
| DDE Clerk Action Items | ||||||
| Review Action Items | X | X | X | |||
| Global Provide Reason | X | X | ||||
| Build Web pages | Grant Access | X | ||||
| Dashboard Report | Grant Access | X | X | X | X | X |
| View Study Status | X | |||||
| Change Study Status | X | |||||
| Data Extraction | Grant Access | X | X | |||
| Deleted Records | Grant Access | X | X | |||
| Undelete Records | ||||||
| Document Manager | Grant Access | X | X | |||
| Delete Uploaded Files | X | X | ||||
| Double Data Entry | Grant Access | |||||
| Form Builder | Grant Access | X | ||||
| Add New Form | X | |||||
| Select Existing Form | X | |||||
| Export To Form Library | X | |||||
| Import From Form Library | X | |||||
| Delete Form | X | |||||
| Save Changes to Form | X | |||||
| Import Manager | Grant Access | X | X | |||
| My Queries Report | Grant Access | X | X | X | X | X |
| Pages Granted to All Users | Grant Access | X | X | X | X | X |
| Query Management | Grant Access | X | X | X | X | X |
| Create Query | X | X | X | X | X | |
| Close Query | X | X | ||||
| Delete Query | X | X | ||||
| Show All Queries | X | X | ||||
| Query Summary Report | Grant Access | X | X | |||
| Randomization | Grant Access | X | X | |||
| Report Builder | Grant Access | X | X | X | X | X |
| Create or Setup Report | X | X | ||||
| Delete Report | X | X | ||||
| Role Security | Grant Access | X | ||||
| Add New Role | X | |||||
| Edit Existing Role | X | |||||
| Delete Existing Role | X | |||||
| Grant Rights to any Role that have not been granted | X | |||||
| Grant Form Rights | X | |||||
| Blind Fields | X | |||||
| Site Document Manager | Grant Access | X | X | X | ||
| Setup Site Documents | X | X | ||||
| Study Configuration | Grant Access | X | ||||
| Import Review Fields | X | |||||
| Configure Functionality | X | |||||
| Configure Role Security | X | |||||
| Configure Site and Users | X | |||||
| Configure Workflow | X | |||||
| Configure QMS | X | |||||
| Configure Version Control | X | |||||
| Configure Metrics | X | |||||
| Configure Audit System | X | |||||
| Configure Double Data Entry | X | |||||
| Subject Audit Report | Grant Access | X | X | |||
| Subject Record Management | Grant Access | X | X | X | X | X |
| Register New Subject | X | |||||
| Edit Subject Registration | X | |||||
| View Subject Registration | X | X | X | X | X | |
| Delete Entire Subject | X | |||||
| Edit Subject Profile ID | X | X | ||||
| Access Subject Records | X | X | X | X | X | |
| Add Subject Event Records | X | X | ||||
| View Subject Event Records | X | X | X | X | X | |
| Edit Subject Event Records | X | X | ||||
| Delete Subject Form | X | X | ||||
| Delete Document | X | X | ||||
| Batch Lock/Sign Record** | X | X | X | X | ||
| Unlock Record | X | X | ||||
| Display Field Change Audit | X | X | X | X | X | |
| Display Subject Migration Diary | X | X | X | X | X | |
| Display Record Diary | X | X | X | X | X | |
| Delete Table Row | X | X | ||||
| Display Review History Table | X | X | X | X | X | |
| Clear All non-provider Data | X | |||||
| Clear All Data | ||||||
| Show Study Build Progress | X | |||||
| Freeze Form | X | X | X | |||
| DDE Clerk | ||||||
| Allow Access to All Subjects | X | X | ||||
| Subject Record page Design | Grant Access | X | ||||
| Text Management | Grant Access | |||||
| Add Text | ||||||
| Change Text | ||||||
| Delete Text | ||||||
| Theme Manager | Grant Access | X | ||||
| Version Control | Grant Access | X |
** Batch and lock permission should only be granted to users that have review levels
Also be sure to read about:
- Form Permissions
- Field Blinding
- Adding users to your account and studies