Role

In the Role tab, the user can add or edit the role information. The system features that are assigned to this role are on the Security tab. System roles, those roles that came with the system, must be copied first by clicking the Copy button, then modified. See images below.

 

Click Save to return to the Roles page.

 

Click Common Buttons for a description of the buttons found throughout the system and their uses.

 

 

Adding a Role

 

 

 

Modifying a Role

 

  1. While editing a system role, such as Project Manager, click the Copy button.

 

 

  1. Modify the Role Name and click the Security tab to adjust the user's access to features in the system

 

 

 

An EDC Role

 

 

 

Field

Description

Role Type

When adding a role, this field is required and the user can select from the choices below. When editing, it is read only.

  • CRO

  • Other

  • Project

  • Site

  • Sponsor

  • System

Role Name

The user can enter up to 50 characters. This field is required.

Role Code

The user can enter up to 10 characters. This field is required.

System Role

When the Role Type is set to Project, this field is required and the user selects from the following choices:

  • Other Role

  • Project Director

  • Project Manager

  • Site Lead Monitor

  • Site Manager

  • Site Monitor

When the Role Type is set to Site, this field is required and the user selects from the following choices:

  • Other Role

  • Principal Investigator

  • Study Coordinator

When the Role Type is set to any other role type, this field is read only and is set to Other Role.

Default Data Access Scope

When the Role Type is set to Site, this field will be set to Single Site. When the Role Type is set to CRO, Other, Project, Sponsor, or System, this field is required and the user can select from the following choices:

  • None

  • Full (Access to All countries and sites and can receive notifications to All countries and sites)

  • Mixed (Access to Selected countries and sites and can receive notifications to Selected countries and sites; Read Only permission to other countries and sites)

  • Restricted (Access to Selected countries and sites and can receive notifications to Selected countries and sites; No permission to other countries and sites)

  • Read Only (Read Only access to All countries and sites and can receive notifications to All countries and sites)

EDC Role

This field will be hidden when the Enable EDC Features configuration variable under the EDC configuration group is set to False. If visible, this field is required and the user can select from the following choices:

  • Data Review

  • Medical Monitor

  • Monitor

  • Other

  • Read Only

Can Cancel Query Source(s):

This field is visible when the EDC Role field is set to either Medical Monitor, Monitor, or Data Review.  The user can select the roles that will be granted permission to cancel the query source from the following choices:

 Data Review

 Medical Monitor

 Monitor

 Other

 System

Can Close Query Source(s):

This field is visible when the EDC Role field is set to either Medical Monitor, Monitor, or Data Review. The user can select the roles that will be granted permission to close the query source from the following choices:

 Data Review

 Medical Monitor

 Monitor

 Other

 System