Metadata Editor Overview

The Metadata Editor enables users to update metadata definitions directly within the platform. It supports efficient iteration and reduces the need for external programming adjustments during review.

Using the editor, users can refine metadata interpretation when discrepancies or incomplete interpretations are identified. Changes are applied to the generation logic and can be used to regenerate the table with updated definitions.

Accessing the Metadata Editor

Users can open the Metadata Editor from:

• The Edit button in the footer of the panel
• The Change View option in the table panel header

Users can open the Metadata editor via the edit Button at the footer of the panel or via the change view button at the table panel header.

What You Can Edit

Within the editor, users can update key metadata components:

• Source dataset used for the analysis
• ADaM variables and values used for calculations
• Statistical calculation methods

Multiple metadata updates can be applied within a single editing session.

Metadata Editor UI initial view (before the user enters a modification)

Guided Metadata Commands

The editor provides a guided command interface to simplify metadata updates.

Users can access metadata operations through a structured command menu, including:

• Dataset selection
• Variable selection
• Statistical method definition
• Metadata component updates

This structured approach helps ensure that metadata changes remain consistent with standard clinical reporting structures.

Metadata commands menu 

Table Regeneration

After metadata updates are saved and applied, the system regenerates the table using the updated metadata definitions.

The regeneration process includes:

• Applying updated metadata definitions
• Recalculating table values from the ADaM dataset
• Rebuilding the table structure
• Updating the comparison baseline

If the regeneration process encounters issues, users are notified and the changes are not applied.

 Regeneration failed error message 

Activity Log Traceability 

All actions performed within the Metadata Editor are automatically recorded in the Activity Log to ensure full traceability of metadata modifications and table regeneration activities.

When a user clicks the "Save and Apply" button, any modifications to metadata components within the editor are recorded. This action logs the metadata change request and its application.

Each modification entry records separately with the following information:

• Location of the change (table ID)
• User performing the change
• Timestamp of the modification
• User request prompt 

These records ensure that all metadata updates performed through the Metadata Editor are fully documented and traceable within the project’s Activity Log, supporting regulatory compliance and validation governance requirements.

The metadata edits are captured in the Project’s Activity Log