Protocol Permissions

eTMFlex has a system of permissions for each user and protocol that is very granular and flexible.

In the Protocol Permissions section, you can configure these permissions for the selected protocol, for either a Profile or a specific Account.

This feature is fundamental as it represents the authorization matrix at the protocol level, providing a clear and controlled overview of access rights and operational capabilities within each protocol. Its implementation is compliant with the regulatory requirements specified in 21 CFR 11.10(d) and EU GMP Annex 11 §12, ensuring integrity and security of access.

Audit Trail

To track changes to protocol permissions, an audit trail is maintained. Each change is logged with the user who made it, the timestamp, and a description of the change.

Protocol Permissions List

Upload document

Allows users to upload documents and fill placeholder in the Data Explorer.
User without this permission can still view and download documents but cannot upload or modify them.

Approve document

Allows users to approve and reject an approval request for an uploaded document.

Delete document

Allows users to delete document.

Ask to delete

Allows users to request deletion of an uploaded document.

Default approver

Default document approver for the selected profile.

Ask to approve

Allows users to ask for document approval.

Create placeholder

Allows users to create placeholders.

Delete placeholder

Allows users to delete placeholders.

Create query

Allows users to create and close queries.

Response query

Allows users to response to queries.

View query

Allows users to view queries.

View Milestones

Allows users to view in read-only Milestones.

Edit Milestones

Allows users to create and edit Milestones.

Delete Milestones

Allows users to delete Milestones.

View Milestones Set-Up

Allows users to view in read-only Milestones Set-Up.

Activate Milestone

Allows users to activate Milestones.

View Milestones Report

Allows users to view Milestones Report.

View Protocol Organizations

Allows users to view in read-only Protocol Organizations.

Create/Edit Protocol Organizations

Allows users to create and edit Protocol Organizations.

Delete Protocol Organizations

Allows users to delete Protocol Organizations.

View Protocol Personnel

Allows users to view in read-only Protocol Personnel.

Create/Edit Protocol Personnel

Allows users to create and edit Protocol Personnel.

View IP

Allows users to view in read-only IP.

Create/Edit IP

Allows users to create and edit IP.

Delete IP

Allows users to delete IP.

View Protocol Profile

Allows users to view associated profiles.

Create/Edit Protocol Profile

Allows users to create and edit profiles.

Delete Protocol Profile

Allows users to delete profiles.

View Protocol Accounts

Allows users to view in read-only Protocol Accounts.

Create/Edit Protocol Accounts

Allows users to create and edit Protocol Accounts.

View Protocol Permissions

Allows users to view in read-only Protocol Permissions.

Edit Protocol Permissions

Allows users to edit Protocol Permissions.

View Protocol Data Dictionary

Allows users to view in read-only Data Dictionary.

Create/Edit Protocol Data Dictionary

Allows users to upload a new Data Dictionary.

View Protocol Tree Permissions

Allows users to view in read-only Tree Permissions (as the Protocol Accounts permission into the Data Dictionary).

Edit Protocol Tree Permissions

Allows users to create and edit Tree Permissions (as the Protocol Accounts permission into the Data Dictionary).