ePROkit Platform 1.x.x
Version date: 5 November 2025
Digital instructions for use are available on the ePRObuilders Dashboard and on the website: eprobuilders.com. Paper format is available on request at support@eprobuilders.com
| Symbol | Detail |
|---|---|
| CE | European conformity mark |
| 🏭 | ePRObuilders BV Andreas Vesaliuslaan 2 2650 Edegem Belgium |
| ⚠️ | This symbol is to indicate an important warning in these Instructions for Use. This symbol can vary in size. |
ePROkit 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 ePROkit platform is composed of:
The ePROkit 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 ePROkit Dashboard for individual review and project-level monitoring.
The Dashboard 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 ePROkit Dashboard also provides the clinical investigation team/clinicians access to individual pages with the clinical information for each participating subject/patient.
The ePROkit 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:
Patients provide data via the ePROkit Mobile App, which may also deliver reminders or alerts when protocol-defined conditions are met. With patient consent, data are shared with healthcare professionals via the ePROkit Dashboard, enabling individual and aggregated monitoring.
The ePROkit Platform is intended for use by healthcare professionals to configure patient interaction protocols, collect patient-reported data, and monitor patients/participants in:
The platform aggregates questionnaire data provided by patients/participants and, when protocol-defined conditions are detected, can notify patients/participants to contact their designated healthcare professional for further follow-up.
The ePROkit Mobile App is used by the subjects/patients while the ePROkit Dashboard is used by the subjects/patients' clinician / clinical investigation team.
In this chapter, you can read the guidelines on how to use the ePROkit Dashboard, intended for clinicians.
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 eprobuilders.com. Contact us at support@eprobuilders.com for any questions.
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.
You can contact us at support@eprobuilders.com for any questions regarding subscriptions and customers that subscribed for a "Pro License" can also contact us to support them configuring their pathways.
To invite a subject/patient, access the ePROkit Dashboard 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 ePROkit app of the subject's/patient's smartphone.
After the activation code has been introduced, please grant the requested permissions in the ePROkit Mobile App to ensure questions and notifications display and function correctly.
The clinicians' Dashboard content might differ from one project to another, but generally you can find:
Per subject/patient you can access the following tabs:
Additionally, clinicians can access overview reports. These reports are custom-made per project and serve as a statistical compilation of pre-defined KPIs useful for the clinical teams.
It's possible to exclude a subject/patient from the project/study. In the subject/patient profile, click the red "Exclude from project" button. Subject/patient data will not be deleted; the subject/patient will no longer receive questions.
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. When requesting export of raw data you will also receive the documentation required for data interpretation (Data Transfer Specifications).
In this chapter, you can read the guidelines on how to use the ePROkit Mobile App, intended for the subjects/patients.
You need an activation code to access the ePROkit App. This activation code will be provided by your clinician (see "Inviting a subject/patient to use the ePROkit Mobile App" above).
⚠️ 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.
⚠️ Note: Please be aware that the ePROkit Mobile App is a communication tool to provide additional support on clinical studies. It is not intended for diagnosis or treatment.
⚠️ IMPORTANT! If you have any urgent medical questions, please contact the hospital/center or your clinician immediately.
If needed, it is possible to remove your account. For this, go to the ePROkit App "Settings", scroll down and tap on "Delete my account".
If you want to remove the Mobile App from your smartphone you can uninstall it.
NOTE: Uninstalling the Mobile App not only deletes the app, but also all its data on the device.
To use the ePROkit Platform, each user should:
⚠️ IMPORTANT! ePROkit 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.
When using the ePROkit Mobile App, keep these points in mind:
When using the ePROkit Dashboard, keep these points in mind:
If you encounter a problem with the ePROkit Platform (Dashboard or Mobile App), clinicians should use the support channels listed in the Dashboard ("Support & Disclaimers"). Participants can use the info button in the mobile app. For general enquiries email support@eprobuilders.com. Support hours: Mon–Fri 09:00–17:00 CET. Typical response time: within 48 business hours.
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. A continuous backup system is used to make sure all data is secure. Other technical and organizational measures exist within ePRObuilders to keep the data safe and accessible.
You, as a user, can also improve the safety of your data, or your subjects/patients' data. For this, it is very important to keep in mind the following recommendations:
Furthermore, as a user, you have several rights with regards to your data. These rights are explained in our Privacy Policy. For all questions and concerns regarding the security of your data, please contact us at support@eprobuilders.com
Data controller: ePRObuilders BV. Personal data are processed in accordance with the EU General Data Protection Regulation (GDPR). For details on processing purposes, legal basis, retention periods and data subject rights, see our Privacy Policy eprobuilders.com/privacy or contact support@eprobuilders.com.
To verify you are using the latest version of the ePROkit Mobile App, go to the App Store from Apple or the Play Store from Google and check if an update is available. It is recommended to set the settings in the App Store and Play Store so that the Mobile App is automatically updated when a new update becomes available.
The ePROkit Dashboard works in all modern browsers such as Firefox, Chrome, Edge, Safari and IE11.
Users will always have access to the latest version of the ePROkit Dashboard since it's a secure website.
The minimum system requirements for the ePROkit Mobile App are:
It is recommended to set the settings in the App Store and Play Store so that the Mobile App is automatically updated when a new update becomes available.
To maintain a fluent workflow of the questionnaire, we recommend ensuring access to the internet regularly (4G/WiFi).
If you found a problem about the ePROkit Platform, including the ePROkit Mobile App, as clinician please contact the support channels which appear in the ePROkit Dashboard "Support & Disclaimers" or as a subject/patient on the info button in the main page of the ePROkit Mobile App. For general questions, please contact us at support@eprobuilders.com
ePRObuilders BV
Andreas Vesaliuslaan 2
2650 Edegem (Belgium)
support@eprobuilders.com
Last revision: 5 November 2025
This IFU replaces previous versions. Please ensure you are using the latest version at eprobuilders.com/instructions