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.


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

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: