Admin audit trail report

  • Published by Viedoc System 2023-10-09
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The Admin audit trail report contains information about all settings and changes of study settings that have been made by authorized users in Viedoc Admin.

Downloading the Admin audit trail report

To download the Admin audit trail report:

1

In Viedoc Admin, open the study settings from the study details page.
2

On the Logs tab, you can generate and download the Admin audit trail report.

If the report was already generated, you can regenerate it to get a report with all the latest information.
3

When you select Download, an Excel file is available in your browser.

The contents of the Excel file

The Excel file contains the following sheets:

  • Report Info - general information about when and by whom the report was generated and some information about the study status
  • Action Logs - a list with detailed information about each action regarding the study in Viedoc Admin. The columns in this sheet are:
    • Area - one of the following values: eTMF, Medical Coding, Reference Data Sources, RTSM, Site Settings, Study Design, Study Settings, User Invitations, User Logs, WCF API client configuration, and Web API client configuration
    • Action - see the table below.
    • Identifier - see the table below.
    • Old Values - list of edited properties with their old values. If making a setting for the first time, the Old Values field is empty.
    • New Values - list of set or edited properties with their new values
    • Reason - if available, a user-entered reason for setting or changing a property. Otherwise, the reason is the same as the action. See also the table below.
    • Date/time - date and time of the action in the format YYYY-MM-DD HH:MM:SS
    • User - display name of the user who performed the action

The following table lists the actions, identifiers, and reasons that are associated with the areas:

Area Action Identifier Reason
eTMF
  • Enable
  • Map roles
 empty

For the Enable action: If switched on, Enable eTMF, if switched off, Disable eTMF

For the Map roles action: Configure access to eTMF
Medical Coding
  • Create a new medical coding instance
  • Edit medical coding
 For the edit medical coding instance action: The sequence and name User-entered reason if available, otherwise the same as the action
Reference Data Sources
  • Edit settings
  • Add reference data source
  • Edit
  • Delete

Unique identifier if available

For the Add, Edit, and Delete actions: The sequence of the reference data source

For the Edit settings action: Edit reference data sources settings

For the Add action: Add reference data source

For the Edit action: Edit reference data source

For the Delete action: Delete reference data source
RTSM
  • Approve settings
  • Uploaded randomization list
  • Add to randomization list
  • Upload individual allocation list
  • Add to individual allocation list
  • Restart

(For dynamic randomizations only): Create configuration, Edit configuration

  • Approve global allocation list settings
  • Mapping for global allocation list
  • Upload global allocation list
  • Add global allocation list

RTSM name or allocation name if available.

For the actions on global allocation, the identifier is Global allocation.

The same as the action if not specified below.

For all the actions that are performed on a specific Production or Demo mode, this is added to the reason, for example, Upload randomization list - Production

For the Approve settings action: Approve RTSM settings

For the Upload randomization list action: Upload randomization list

For the Upload individual allocation list action: Upload allocation list

For the Add to randomization list action: Add to randomization list

For the Add to individual allocation list action: Add to individual allocation list

For the Restart action: Restart RTSM

For the Edit configuration action: Edit RTSM configuration

For the Create configuation action: Create RTSM configuration
Site Settings
  • Add new site
  • Edit site
 The site number The same as the action
Study Design
  • Assign design
  • Apply revision
 Design or revision name and version The same as the action
Study Settings
  • Add Study
  • Edit study settings
  • Edit date & time format
  • Edit medical coding
  • Import ODM file to Demo
  • Import ODM file to Production
  • Edit documentation
  • Archive documentation
  • Restore documentation
  • Delete documentation
  • Lock study
  • Unlock study
  • Request study deletion
  • Approve study deletion
  • Reject study deletion
  • Revert study deletion
  • Enable item level SDV

For the edit medical coding action: the coding scope

For the documentation actions: the section name

For the Add study action: Create study

For the other actions: User-entered reason if available. Otherwise, the reason is the same as the action.
User Invitations
  • Invite user
  • Delete invitation
  • Reset password
  • Resend invitation
  • Remove user role from study

Unique identifier if available.

For the reset password action:

  • User = user display name
  • Email = user email address
 The same as the action
User Logs
  • Generate log of users and roles
  • Generate user administration log
  • Generate user communication log
 empty The same as the action
WCF API client configuration
  • Add
  • Edit
  • Delete
 Client ID (GUID)

For the Add action: Add API client

For the Edit action: Edit API client

For the Delete action: Delete API client
Web API client configuration
  • Add
  • Edit
  • Delete
 Client ID (GUID)

For the Add action: Add API client

For the Edit action: Edit API client

For the Delete action: Delete API client

Note! Some data might not be available for the actions performed before the release of Viedoc 4.72.