Managing Protocol Specific Users On Protocols

Vestigo provides the means to allow internal users read-only access to Vestigo to fulfill their job 
responsibilities. Protocol Specific User’s view mirrors what an external monitor would see. As a reminder, Vestigo is considered an unblinded system and blinded users should not be listed on the protocol or given access to Vestigo.

Required Permissions

ProtocolSnapshot - Ability to view the Summary page of a Protocol (Protocol Snapshot). Required for all other protocol view permissions.

ViewContacts - View contacts in a protocol. Protocol Snapshot permissions are required

EditProtocolContacts - Ability to edit Protocol Contacts tab. Protocol Management permissions are required

Contents

1. Protocol Contact Roles
2. Creating a Protocol Specific User
3. Adding a Protocol Specific User to a Protocol
4. Removing a Protocol Specific User from a Protocol

Protocol Contact Roles

Access is restricted to specific protocols as authorized by contact roles through the “Protocol Contacts” tab within each protocol. Individuals external to the organization, such as monitors or sponsors, should be provided with read-only access via the monitor pathway. 

There are four system provided contact roles in Vestigo for Internal Reviewer/Study Coordinators:

• Internal Reviewer/Internal Auditor

• Study Coordinator

• Study Coordinator no Access

• Study Coordinator with Returns*

^{* This Contact role is Inactive by default, but can be turned on by Vestigo support if requested.}

Assigning a contact one of these roles along with “Protocol Specific User” access in Application Administration allows them Read Only access to that protocol in Vestigo. The Study Coordinator and Internal Reviewer roles grant the same access when paired with “Protocol Specific User” status.

A contact who is a Protocol Specific User can be added to other protocols as a role that does not grant access. The role “Study Coordinator no access” can be used when a Protocol Specific User is added to a protocol as a contact but should not have access to that protocol when logging in. 

“Study Coordinator with Returns”, has the same read only access as Internal Reviewers/Study Coordinators however, they have added functionality to enter returns against patient dispenses. For more information on that function, please review this KB article.

Creating a Protocol Specific User

This section may be skipped if the user already has a protocol Specific access account. If the user does need an account created, please review this KB article covering the account creation process.

Adding a Protocol Specific User to a Protocol

1. Navigate to the protocol
2. Click Edit Protocol
3. Click the Contacts tab
4. Select Add New
5. Locate the user in the dropdown list
6. Select one of the roles mentioned above
7. (Optional) Adjust the Authorized Prescriber status
8. (Optional) Add a Start Date for tracking purposes
9. (Optional) Add an End Date for tracking purposes
   

   Tip - Once the end date is reached, the contact role will automatically become inactive on the protocol and access to the protocol will not be available for that user.

    

10. Click Submit

Removing a Protocol Specific User from a Protocol

1. Navigate to the protocol
2. Click Edit Protocol
3. Click the Contacts tab
4. Locate the contact with the Protocol Specific Access and click Inactivate
5. Click Confirm to complete the inactivation process