SMART-TRIAL Launches Reporting Module

July 18, 2023
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SMART-TRIAL Launches Version 2023.3

SMART-TRIAL 2023.3 is here, and that means we get to release our Reporting Module. Please note that to be able to access this module, you will need to activate it for the particular study you want to use it for, as well as have the ''Reporting'' permission enabled. Read on to find out more about the module and how to enable it, or read our help article.

Reporting Module - Full Data Overview in One Place

This module will act as a bridge for multiple data viewpoints. Data managers, monitors, and sponsors will have real-time overview of key data and study progress, as we're bringing unscheduled events, adverse events and forms data into one view, or table.

Let's take a look at what benefits this overview brings to the following roles:

  1. Data managers
  • aggregated view on form completion, data completion and verification status
  • faster data overview
  • quicker outline of different data points
  • ability to see missing data ahead of a site visit or important study time points
  • ability to check completion status of data events or important forms

     2. Sponsors

  • reliable and real-time reports
  • ability to make quicker decisions on improving collaboration with sites, if needed
  • get an overview of unscheduled event forms (e.g. protocol deviations or device deficiencies)
  • check the Verification status/progress of the study
  • check that monitors are on track with their monitoring of: critical variables, forms, data events
  • prepare for interim analysis / database lock by ensuring the relevant data events/forms have been prepared and are ready for export

     3. Monitors / CROs

  • ability to review at a glance what sites have done
  • ability to react in real-time to presented data
  • get an overview of unscheduled event forms (e.g. protocol deviations or device deficiencies)
  • check event timing to see if date of visits/procedures etc have been conducted after e.g. informed consent signature time
  • find missing data ahead of a site visit or important study time points

Reporting Module - In Detail

Next, we will provide a short walkthrough of the module. If you prefer to watch a short demonstration instead, here it is:

We mentioned at the beginning of this article, that users will have to activate the module for specific studies.

To activate this for an existing study, go to ''Study Info'' -> ''Edit Study'' and choose ''Add-ons''. Then toggle ''Reporting'' on.

The last step is to go to "Collaborators'' and assign the right colleagues the permission to access ''Reporting''.

For newly created studies, you just need to enable the add-on and the module will display on the left-hand side panel. If you want to update collaborator permissions, and enable the reporting module for other team members you can do so as usual.

Clicking on ''Verification'' will take you to the Reporting table / overview. The system will now perform its first full sync. This can take anywhere from 5 to 45 minutes, depending on the amount of data in your study. After the initial sync, the table will update as changes occur in your study. Make sure to use the ''refresh'' button / icon - right next to ''Columns'' for new data to display.

In the picture below you can see the Reporting Module in action, with the ''Data Points'' table. At the moment it is only possible to get an aggregated view of questions, answers, verification, enrollment & form status, sites, and data events data.

The ''Data Points'' table makes it possible to monitor the status of specific data events for a particular site/s. You can also see all questions linked to a specific site, answers, answer status and verification status.

It is also possible to get a high-level overview of all forms, with creation time, status, data points for each form, etc.

The third view is ''Data Events''. In here, users can get a quick overview of the status of all data events (including Adverse events and Unscheduled events).

The Columns button will allow users to customize their reporting view / table with only relevant data for specific use cases, by toggling on/off. Each column can also be dragged around and reordered.

The setup will be saved, and is unique to a user's profile and study, so it looks the same when you come back next time.

Lastly, remember to use the refresh button often to get an updated overview of your data. Do so by clicking on the ''Refresh'' icon on the top-right side.

Filtering Options

The Reporting module comes with a lot of filtering options available to narrow down the data overview even further. It is well worth spending time creating good filters than can be re-used at a later time.

For more information on these filtering options and how to use the quick filter, please head over to our help site.

Other Improvements and Fixes

To review all other improvements, changes, and fixes, visit the official SMART-TRIAL Changelog.

Thoroughly Validated Software

For every SMART-TRIAL release we conduct thorough verification and validation of all system requirements. All SMART-TRIAL releases are validated according to SMART-TRIAL’s state-of-the-art quality management system to ensure compliance with relevant industry standards.

For quality assurance, you can download the 2023.3 release certificate here.