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Audit Log

Each study in SMART-TRIAL has its own independent audit log where every user action in the study is logged. 

You can access the audit log in a study using the left side menu, assuming you have the "audit log" permission.

Audit log permission should only be given to users who may need to look back in time and who is allowed to see study data + personal identifiable information, as the audit log is a TOTAL collection of everything that has happened in the study.

Filtering

The audit log quickly becomes quite massive, as all actions are logged. It is therefore of great benefit to use the filtering to narrow down ones searches and then by the end go by timestamps.

Currently, it is possible to filter by the four categories: Subject, Actor, Model, and Operation.

Subject

It is possible to filter for one subject at a time

Actor

Actor is the user who performed the action, it is possible to filter for one actor at a time.

Model

Model is the "element" that was interacted with. Below is a table of all the models available and what they cover.

Site Statistics The statistics that can be found in the site overview (number of forms filled, number of subjects)
Form link Data events and unscheduled events interactions
Site Interactions with sites as found in the Sites Overview, not a specific site overview
Subject Anything to do with subjects or lists of subjects (as found on a site overview)
Form  Form Templates, i.e. the ones you create that contain no subject data
Question Template Question types and interactions (e.g. save possibilities)
Process Processes in the study
Form Answers Question answers in forms. Use this to see who has edited data
Collaborator Collaborators in the study
Study The study settings + status (can be found in the Study Overview by clicking "edit study")
Study Test If test mode was started or stopped
Enrollment Record A subjects enrollment or a list of enrollments
Study Data The "Data" module in the left side menu
Adverse Event Anything to do with adverse events
Medication Anything to do with Medication and Accounting
Data Event Not really triggered directly.
Consent Whether subjects have interacted with the public signup consent
Public One Time Password Only has entries if subjects are required to enter a OTP to access their questionnaire
Export Data One Time Password Every time a user accesses the export view
Study Overview Data A specific export that contains "Study Overview Data"
Form Data Any data related to forms that has been exported
Discontinued Data Any data related to Discontinued events that has been exported
Unscheduled Data Any data related to Unscheduled events that has been exported
External Data Any external event data that has been exported
Query Query actions performed in the study
Amendment Amendments start, finish etc.
Translations Interactions with the translation module
API Key If the API key has been accessed
API Key Settings If the API key settings have been interacted with
External event information Study info you see in the external data view
Randomisation record Subjects who have been randomized
Hook Interactions with the webhook/alert module
Validation Rule Reference rules 
Answer File Uploaded files
Export Request Any and all export requests made in the study and interactions with exports

Operation

Operations are performed on the Models. Not all operations are valid on all Models.

  • Create
  • Edit
  • View
  • List
  • Delete
  • Accept
  • Decline
  • Discard
  • Finish
  • Lock
  • Unlock
  • Edit Translation
  • List Translations
  • Sign Off
  • Export
  • Duplicate
  • Verify
  • Unverify
  • Verify(2)
  • Unverify(2)
  • Upload
  • Download
  • Remove
  • Restore

Actions

There are two actions that can be performed in the audit log.

These are "View Difference" and "Go to Object".

View Difference will display the object before and after an edit or change.

Go to Object will take you to the object (subject/form etc.) - this operation may fail if the object no longer exists. This might be the case if you try to access an object that existed in a test mode that is no longer active or has been deleted.

Exporting the Audit log

The export of the Audit Log is handled by the SMART-TRIAL support team since exporting Audit Log is quite time consuming due to the size of the Audit Log. In order to get an export of the Audit Log, you need to make a support request to us (support@smart-trial.com) asking for an export of your study/studies. The process for exporting the Audit Log is as follows:

  1. An export is requested for a study
  2. A support agent picks up the request and asks for required information and permissions to the study
  3. Once the information and permissions are in place, a backup of the study is deployed on a secure machine, and export is performed
  4. The exported logs are shared through our file-sharing server, protected with your SMART-TRIAL credentials
  5. Once you have confirmed that the logs are downloaded, we delete the logs from our file-share

To export the audit log, the support team will ask you for:

    • Identification of what study/studies the Audit Log should be exported from (e.g. the study name)
    • Access to the Audit Log of the study/studies in question (access can be granted through the Collaborators view).
    • A little bit of patience (it usually takes 2 workdays for us to generate the export)