How to read the Subject Audit Trail

The subject audit trail tracks and documents every action within Climedo to reconstruct the course of events for a specific subject.

Users with audit trail reading rights can access the audit trail for subjects of a study via the navigation sidebar.

1. How to set filters

The audit trail filters help you to navigate through the typically large amount of audit trail logs that are collected in the presented table. You can combine all filters and remove the filter queries by clicking the “clear all filters” button.

Filter Overview:

• Subjects: select one or more subjects for which you wish to display the audit trail logs
• Input Forms: select one or more input forms that have been added to the study’s workflow
• Operation: selecting an operation further helps to narrow down and search for specific audit trail logs you’re interested in. See the list of available operations with examples below:
  • Added: input forms, fields or subject information are initially added
  • Archived: subjects or (S)AEs are deleted
  • Created: subjects or (S)AEs are created
  • Updated: input forms, fields, subject information or queries are updated
  • Deleted: input forms or fields are removed (e.g. also due to dependencies)
  • ePro opened: subject opened the ePro link sent via email or SMS
  • ePro sent: ePro was sent to subject via scheduled trigger or manual action
  • Exported: for (un)scheduled events, (S)AE, subject profile or query export
  • Locked: input form is locked
  • Unlocked: input form is unlocked (e.g. due to corrections to be made(
  • Marked available: input field is marked as available if it was marked as unavailable before
  • Marked unavailable: input field is marked as unavailable, e.g. if data entry does not apply
  • Signed: input form is signed
  • Unsigned/Signature dropped: input form is unsigned, e.g. due to updates to be made
  • Renamed: subject files and folders have been renamed
  • Triggered: notification is triggered due to defined trigger event
  • Randomized: subjects have been randomized
• Collaborator: choose a specific collaborator if you’re interested in the actions they made
• Site: show all audit trail logs for all subjects of a specific site
• Timestamp: narrow down your search by applying time based filters (today, last x days, this month etc.)

2. How to read the Subject Audit Trail Table

The audit trail table offers a broad overview of all audit trail logs for a specific study or survey, assigned to a specific subject. You can directly navigate to the respective action or have a look at more detailed information for this event .

The primary, secondary and tertiary information as well as the operation column give you more insights on the event itself and help you to understand the context of the event right away.

The remaining columns state who exactly performed a certain action (collaborator name, role and site assigned) as well as at what exact timestamp the action was performed.

3. Detailed Changes

Clicking on the eye icon opens up the detailed changes for one specific event. Here, you can find the full list of detailed information to reconstruct the action made. For example, for field update events, you can view the update history, i.e. the old and new values as well as the reason given for the change if this functionality is enabled.

4. Export

You have the option of exporting the Subject Audit Trail. Read more about this in the following article: How do I export data of my study?

Video

How does the audit trail work?

To ensure GCP compliance, customers can use the Subject Audit Trail to track all input and data changes. In this videos, we will show you how to find and export the Audit Trail. Please note that you need specific role permissions to view it.