What to look for in an ePRO system

Electronic Patient/Participant Reported Outcomes (ePRO) capture data directly from participants rather than through clinical staff. When done well, the result is timely, accurate, real-world data. When done poorly, it is a source of compliance gaps, missing submissions, and frustrated participants.

Choosing the right ePRO system matters more than most teams initially appreciate, and it's worth being sceptical of vendors selling novelty over usability. Here are nine features worth evaluating carefully.

1. Translation and multilingual support

Limiting a study to one language restricts the diversity of the participant population and introduces selection bias. A good ePRO system should support multiple languages, including right-to-left scripts where needed, and make it straightforward to add translations without rebuilding the entire form.

2. Data validation and field limits

Erroneous entries are hard to detect and harder to resolve. Fields should enforce appropriate data types and logical ranges: a height field should not accept 400 metres. Required fields ensure that key data points are not accidentally skipped. These constraints protect both data integrity and participant safety.

3. A genuinely easy-to-use interface

Participants vary enormously in their familiarity with technology. An interface that feels intuitive to a developer may be confusing to a participant using a smartphone for the first time. The test is whether someone with no training can complete a submission without making errors, not whether the design looks polished in a demo.

This is also where it's worth resisting the pull of whatever interface feels most novel. A usability study comparing three ePRO interface types head-to-head, a traditional app, a chatbot, and a voice-operated Alexa skill, found that a large majority of participants (83%) preferred the plain app interface once they'd actually tried all three, citing speed, ease of use, and portability as the deciding factors. The conversational and voice interfaces sounded more modern on paper. They didn't win in practice. If a vendor is pitching an interface novelty as the headline feature, it's worth asking to see it tested against the plainest possible alternative first.

4. Auto-save and draft submissions

Longer questionnaires should allow participants to save progress and return. Unexpected interruptions, poor connectivity, or accidental browser closure should not result in lost data. Auto-save removes a significant source of dropout and incomplete submissions.

5. Offline capability

Connectivity is not universal. Participants in rural areas, or those completing submissions during travel, need a system that can work without a live internet connection and synchronise data when connectivity is restored. An ePRO that requires constant connectivity will produce gaps in data collection from exactly the populations that most benefit from remote participation.

6. Multiple support channels

Ethics committees expect to see evidence that participants can get help when they need it. The ePRO system should make it straightforward to contact the study team through multiple channels: in-app messaging, email, telephone, or SMS. For studies involving participants with health conditions, accessible support is not just a nice-to-have.

7. Integration with other platforms

A good ePRO system should connect to your existing infrastructure rather than creating a parallel data silo. Integration with wearables, CTMS platforms, and EDC systems reduces manual data transfer and the errors that come with it. Vendors that are reluctant to discuss integrations or require proprietary workarounds are worth treating cautiously.

8. Co-development flexibility

Every study is different. The best ePRO vendors treat their clients as partners and are willing to develop features or configurations beyond their standard offering. If a vendor cannot tell you clearly how custom requirements are handled, that becomes a constraint the moment your study needs something they did not anticipate.

9. Encryption and security

Participant data, particularly health-related data, requires strong protection. Encryption in transit and at rest, GDPR and HIPAA compliance, and clear documentation of how data is stored and who can access it are baseline requirements. Ask the vendor to be specific about their security architecture rather than accepting high-level assurances.

The pattern across all nine

Almost every point above resolves to the same underlying question: does this feature reduce friction for the participant actually submitting data, or does it just look impressive in a sales demo? The usability research above is a useful gut-check for the whole list, not just point three. A feature that a vendor is proud of and a feature that a tired participant, filling in a form on their phone at the end of a long day, actually benefits from are not always the same thing. Evaluate accordingly, and where possible, test candidate platforms with a handful of real participants from your target population before committing, rather than relying entirely on a vendor's own demo environment to make the case.