Instructions for Use

1. Symbols

2. Product Description

ePRObuilders platform is a digital data-gathering platform that enables clinical teams and clinicians to monitor clinical investigations, post-operative follow-up, remote patient monitoring and patient support programs by remotely collecting data from participants. Participants provide information via self-assessments by completing questionnaires that form part of study or care protocols. When a protocol-defined condition is detected, the platform notifies participants and prompts them to contact their designated point of contact for follow-up.

The ePRObuilders platform is composed of:

ePRObuilders Mobile App (iOS, Android) for participating subjects/patients:

The ePRObuilders Mobile App enables Subjects/patients to complete predefined, longitudinal questionnaires and receive study- or care-related information and reminders. If responses meet a protocol-defined threshold, the app advises participants to contact their clinician. With participant consent, data are shared with healthcare professionals through the ePRObuilders Dashboard (ePROkit) for individual review and project-level monitoring.

ePRObuilders Dashboard (ePROkit) for clinical investigation team members/clinicians:

The Dashboard (ePROkit) allows clinicians to configure participant interaction protocols and view both individual and aggregated clinical data collected from participants. This information is presented in the form of a dashboard. The Dashboard (ePROkit) also provides the clinical investigation team/clinicians access to individual pages with the clinical information for each participating subject/patient.

General Description

The ePRObuilders Platform is a digital system that enables subjects/patients to complete structured (longitudinal) questionnaires and receive study- or care-related information. Depending on the protocol or program, the platform can support:

• Clinical investigations (e.g., electronic patient-reported outcomes, safety monitoring),
• Post-operative follow-up,
• Remote patient monitoring in routine care, and
• Patient support programs initiated by healthcare providers or sponsors.

Intended Use

The ePRObuilders Platform (ePROkit) is intended for use by healthcare professionals to configure patient interaction protocols, collect patient-reported data, and monitor patients/participants in:

• Clinical investigations,
• Post-operative recovery programs,
• Remote patient monitoring, and
• Patient support programs.

Users

The ePRObuilders Mobile App is used by the subjects/patients while the ePRObuilders Dashboard (ePROkit) is used by the subjects/patients' clinician / clinical investigation team.

3. Steps for Use

ePRObuilders Dashboard (ePROkit) – Clinicians

Setting up your clinician account

You need a personal account to create your subjects/patients interaction protocols, monitor and manage the health of your subjects/patients. A personal account can easily be created on the website www.eprobuilders.com. Contact us at support@eprobuilders.com for any questions.

Creation of your subjects/patients interaction protocol

Once an account has been created, you can start configuring your subjects/patients interaction protocol following the tutorial videos available in your account. The number of available features depends on the license you subscribed to.

Inviting a subject/patient to use the ePRObuilders Mobile App

To invite a subject/patient, access the ePRObuilders Dashboard (ePROkit) and click on the "Create new subject/patient"/ "Create new subject/patient ID"-blue button. Fill in the required fields. Once the subject/patient is added, an activation code will be shown which should be introduced in the ePRObuilders app of the subject's/patient's smartphone.

After the activation code has been introduced, please grant the requested permissions in the ePRObuilders Mobile App to ensure questions and notifications display and function correctly.

Monitoring the data of subjects/patients

The clinicians' Dashboard content might differ from one project to another, but generally you can find:

• Overview of the total onboarded subjects per stage.
• Overview of open ASRs (Additional Safety Reports).
• List of subjects onboarded.

Per subject/patient you can access the following tabs:

• "Data" - Questions and answers with timestamps
• "ASRs" – (Additional Safety Reports). Up to three notification levels can be configured:
  • Medium: Less urgent, visible on the Dashboard and included in the daily email overview of outstanding ASRs.
  • High: prioritised over Medium; triggers an email to designated clinician(s) when activated.
  • Urgent: configured as Immediate; notifies designated clinician(s) by email and Dashboard alert and sends an in-app message to the participant advising contact with the hospital.
• "Edit settings" - Some projects require the possibility to modify for example: the first date of the study drug or the Subject ID/Patient ID.
• "Activation codes" - Visualization of the activation code created for a subject/patient.
• "Subject/patient Monitoring" - Overview of the subject/patient Response Rate.
• "Subject/patient Report" - Custom-made reports made per project which reflect different statistics on subjects/patients' answers.

Downloading clinical data

If you have the appropriate admin rights, you can request an export of raw data via "raw data export" on the Dashboard main screen. After the export is prepared you will receive an email from reports@eprobuilders.com with a secure download link.

ePRObuilders Mobile App – Subjects/Patients

Downloading the ePRObuilders Mobile App

1. Find the ePRObuilders app in your app store. There are 3 ways to do this:
   • Scan the QR code to open the app store page.
   • Go to the respective iOS or Android app stores and search for ePRObuilders.
   • Go to https://api.eprobuilders.com/app_store on your mobile phone.
2. Install the ePRObuilders app like any other app.
3. ⚠️ Allow the permissions asked in the ePRObuilders app in order to display the questions/notifications correctly.
4. If the questionnaire is available in more than 1 language, select your preferred language.
5. Accept the Terms of Use and Privacy Policy
6. Activate the app using the Activation code provided by the site/hospital.
7. Fill in Subject/Patient ID as provided by the site/hospital.

⚠️ Note: A network connection (Wi-Fi, 3G, 4G or 5G) is required for the mobile app to download questionnaires and upload answers. The app can operate offline for short periods but requires periodic internet access to synchronise data with the clinicians' Dashboard.

⚠️ IMPORTANT! ePRObuilders Mobile App is a communication tool that provides additional support. It is not intended for diagnosis or treatment. If you have any urgent medical questions, please contact the hospital or your doctor immediately.

4. Important Safety Information

General safety information for all users

To use the ePRObuilders Platform, each user should:

• Have an email address (only required for ePRObuilders Dashboard (ePROkit) users).
• Have basic computer and internet knowledge.
• Be willing to use the ePRObuilders Platform.

Performance issues

If you encounter a problem with the ePRObuilders Platform, contact us at support@eprobuilders.com. Support hours: Mon–Fri 09:00–17:00 CET. Typical response time: within 48 business hours.

Data protection & data security

ePRObuilders uses industry-standard encryption protocols to secure all products and data in transfer and at rest. The data is only stored on secure, encrypted servers in the EU and not on the device of the user.

You, as a user, can also improve the safety of your data by:

• Using a complex and unique password for your login
• Never sharing your credentials
• When using a public computer, logging out of your ePRObuilders session
• Using a secure internet connection

Data controller: ePRObuilders BV. Personal data are processed in accordance with the EU General Data Protection Regulation (GDPR). For details, see our Privacy Policy or contact support@eprobuilders.com.

5. Compatibility

ePRObuilders Dashboard (ePROkit) - Clinicians

The ePRObuilders Dashboard works in all modern browsers such as Firefox, Chrome, Edge, Safari and IE11.

ePRObuilders Mobile App - Subjects/Patients

The minimum system requirements for the ePRObuilders Mobile App are:

• Android: Android 5 and higher (Android Go devices included, BLU devices excluded)
• iPhone: iOS version 11 and higher
• Tablets: The app should work on tablets but is not designed with tablets in mind

6. Support

For general questions, please contact us at support@eprobuilders.com

7. Manufacturer

ePRObuilders BV
Andreas Vesaliuslaan 2
2650 Edegem (Belgium)
support@eprobuilders.com

Last revision: 15 September 2025

This IFU replaces previous versions. Please ensure you are using the latest version at eprobuilders.com/instructions