History report details

As part of a study decommissioning package, some regulatory agencies require the following history reports.

Table 1-2 History report details

Report name	Description	Included in the .zip file
Audit Trail Report	This report includes traceability details for item-level inserts and edits, query changes, form status changes, SV status changes, and comment and signature history. This report is only available in CSV format.	One folder per site, each containing one CSV per subject. Table of Contents Request Settings A cumulative CSV file containing details for all subjects.
User Assignment History report	This report includes an audit history of changes made to each user account. User status changes, such as created, activated, deactivated, and terminated. Query group changes Reporting group changes Rights group changes Signature group changes Site association changes	One folder per site, each containing one CSV file with details for users at the site. Table of Contents Request Settings

Report name

Description

Included in the .zip file

This report includes traceability details for item-level inserts and edits, query changes, form status changes, SV status changes, and comment and signature history.

This report is only available in CSV format.

One folder per site, each containing one CSV per subject.
Table of Contents
Request Settings
A cumulative CSV file containing details for all subjects.

User Assignment History report

This report includes an audit history of changes made to each user account.

User status changes, such as created, activated, deactivated, and terminated.
Query group changes
Reporting group changes
Rights group changes
Signature group changes
Site association changes

One folder per site, each containing one CSV file with details for users at the site.
Table of Contents
Request Settings

Parent topic: Access Oracle InForm CRF Submit to generate an archive or history report