Auditing Changes to Integral Data

Audit Reports are performed on files existing in the Data, Lib, or Experiment(s) folders only; folder changes are not included. However, a report can be initiated from the folder level (e.g., a Project or Experiment(s) folder), which will walk the folder/file tree and recursively create a report that includes all applicable files.

To generate an audit report for a folder

To generate an audit report for a file

Audit report contents

To generate an audit report for a folder

AuditReportFolder.png 

  1. Go to the History tab of a folder.

  2. Click the Generate Audit Report button.

  3. In the popup, check the box for Include File Diffs if you want to include a comparison of the two most recent revisions of each file.

    Click Save to generate the report and save it to your local directory as a .zip file.

To generate an audit report for a file

AuditReportFile.png 

  1. Go to the History tab of a folder or file.

  2. Click the Generate Audit Report button.

  3. In the popup, check the box for Include File Diffs if you want to include comparison of revisions in the report.

  4. If Include File Diffs is checked, use the radio buttons to specifying the revisions to compare for differences.
    Most Recent VS Prior: If the file had 3 revisions, this option would compare revision 3 with 2.
    Most Recent VS First: This option would compare revision 3 with 1.
    Custom: Use the two pull-down menus to select the revisions to compare.

    Click Generate Report to generate the report and save it to your local directory as a .zip file.

Audit report contents

Compliance with 21 CFR Part 11 requires full accountability for all changes to study data, including inserting, deleting, and modifying data. Integral captures information for the following event.

Reported in the Revision Changes section of the audit report:

adding a file

adding a new revision of a file

editing content of a file

deleting a file

creating/updating links

creating/updating copies

Reported in the Property Changes section of the audit report:

locking/unlocking

blinding/unblinding

For each event, the following information is collected:

username

date/time of modification (in UTC)

commit ID

The report itself is a .zip file that contains:

A main summary Report, in PDF format. A list of the files included in the report and if a Diff file is available is followed by a separate section for each file in the list. Each file’s section has three parts:

File summary: This section shows the name, path from the repository, author, creation date, size, and description of the file.

Revision changes: For each revision of the file, the author, revision creation date, commit ID, and reason for the revision are presented.

Property changes: For each change to a property in the file, the name of the property, the value, the date/time of the change, and the author of the change are presented.

A file for each Diff (if requested). For text files, the Diff file is a PDF file showing a side by side com­parison. For dataset files (CSV files or CDISC datasets), the Diff file is an Excel file listing the Column Name, Action, Previous Value, Current Value, User, and Commit ID.

Note:The audit report captures changes to files, but not folders. Therefore, not all commit IDs will be found in an audit report. However, all actions are captured in the background and can be retrieved by submitting a support ticket.

 


Last modified date:5/18/21
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