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).