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 iOS
The 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