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:
- An export is requested for a study
- A support agent picks up the request and asks for required information and permissions to the study
- Once the information and permissions are in place, a backup of the study is deployed on a secure machine, and export is performed
- The exported logs are shared through our file-sharing server, protected with your SMART-TRIAL credentials
- 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)