Role Permissions Template

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After the study roles have been configured, this template can be used to set permissions for common roles in clinical research.

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

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