SMART-TRIAL launches ISO14155:2020 Compliant AE Reporting Module for Medical Device Studies

August 8, 2020
.  written by 

SMART-TRIAL 2020.2 includes one of the most awaited features to date - a customisable AE/SAE module. The updated module enables MedTech clinical teams to comply with ISO14155 and other regulatory requirements for AE/SAE reporting in Clinical Investigations and PMCF studies. SMART-TRIAL 2020.2 is available to all user from today.

The Adverse Events Reporting Module - Compliant, Customizable and Consistent 

While we waited in anticipation for the 2020 update of the ISO 14155 standard, the SMART-TRIAL team was working hard on implementing updates to the Adverse Event module. The newly updated AE/SAE module offers:

✓ Regulatory Compliant AE/SAE Workflow
✓ Ready-to-use Regulatory Compliant Templates
Customizable AE Forms
✓ Clear Overview of all Safety Events
✓ Automatic Email Notifications

Comply but also Customize 

Setting up an AE Form is no different than setting up a regular Form. The real magic is in the options, by e.g. adding and removing questions as needed. The revamped AE module lets you control who answers which questions and when (e.g. sponsor, investigator, study nurse).

To make it easier to comply with international standards on Adverse Event Reporting, SMART-TRIAL now offers AE Form Templates that are ready-to-use. We provide you with a few templates that you can choose to "use as is" or customize them to fit your study.  When you select an AE Form Template the Form appears with questions and the appropriate settings allowing you to adhere to e.g. ISO14155 or standard ICH GCP AE reporting. The questions that appear in the template have been extensively researched by the product team so you can focus on collecting the data.  There will be two AE Form Templates dedicate to comply with ISO14155 and MDR/MDD, and one for standard ICH GCP.

Select an AE Form from pre-defined templates

Form Customization 

If your study is more complex, you now have the option to customize the AE template. Add questions that are specifically related to your study and select how much the sponsor should be involved in the AE workflow.

The focus here is to let you decide how AE data should be collected for your study.

Learn how to create a custom AE/SAE Form →

No More Delays with Automatic Reminders 

Specify who should be responsible for each area of the AE report e.g. Investigator and Sponsor specific permissions. The revamped AE module notifies sponsors immediately, but you can also customize the notifications under the "Study Notifications" menu to the left.

Auto-Complete and Auto-Validate Settings

Based on the answers selected, only relevant fields will be shown or auto-completed with subject information that’s available from within SMART-TRIAL. For example, it will automatically include gender, date of birth, or birth year if they are used as subject attributes.  With the introduction of new mandatory options, you can select at which stage during the AE report fill out the question should be mandatory. We’ve also added fill out permissions so you can select which collaborator permission is required to fill out the question (reporter, investigator or sponsor).

When filling out AE’s you will notice a change to the layout. You can verify and generate queries on individual fields in your AE Form just like you would on a normal Form.

Learn how to use the new AE/SAE module →

Reducing Workload and Stress with Full Overview

From the AE/SAE Report list, you can find all Adverse Events reported in the study, with an overview of their severity and progress. An overview of the progress of individual reports is seen at the top of each report. Not having to search for paper-based reports, or checking on site-staff to get an overview of AE/SAE status saves time.

Sponsor has classified the event

Faster Reporting to NCA with MDD & MDR Compliant Export

With just a few clicks you have the possibility to export all Adverse Events in a study. Just select the Adverse Event data from the "Export" view. The process of reporting AE/SAE to national competent authorities (NCA) has never been easier.

Get started with the new AE module

Join the SMART-TRIAL 2020.2 Release Webinar

SMART-TRIAL 2020.2 Release Webinar

We are hosting a walk-through webinar where SMART-TRIAL's product manager, Rasmus Blendal, will take you through the updated module and more. You will learn:

  1. An introduction to the new Adverse Events Module
  2. How to customize the AE Form to your study
  3. How to migrate from the old AE/SAE module

Register now!

Other Improvements

To review all other improvements, changes, and fixes visit the Official SMART-TRIAL Changelog and join the release webinar ⇣

View changelog →

Release Certificate

For every SMART-TRIAL release, we conduct thorough verification and validation of all system requirements. For quality assurance, you can download the 2020.2 release certificate here.

↓ Click the image to download the certificate ↓

Release Certificate
SMART-TRIAL  2020.2 Release Certificate

If you have any questions you are always welcome to contact us via