ePRO (electronic patient-reported outcomes)
Domain focus and core rules
This domain tests whether you can run ePRO in a regulated trial without breaking data integrity, instrument validity, or patient usability. ePRO is PRO data entered by the patient into a device; it is not clinician-reported data transcribed later. eCOA is the broader category that also covers clinician- and observer-reported outcomes.
- Source and attribution: the patient's entry is the source record. It must be attributable, contemporaneous, original, accurate, legible, and durable (ALCOA+). Under FDA's 2013 electronic source data guidance, expect audit trails, controlled access, and secure retention; 21 CFR Part 11 applies to electronic records and signatures.
- Instrument control: use a validated, licensed PRO and its approved electronic migration. Equivalence may require cognitive debriefing, usability testing, and measurement-equivalence evidence; translation and cultural validation are separate from software localization.
- Device model: provisioned devices give control over version, clock, and access; BYOD reduces burden but demands OS/browser validation, privacy safeguards, and support for varied screens. Lock or verify time settings and prevent patient edits to the device clock.
- Timing and reconciliation: diary windows, time-zone rules, reminders, and compliance thresholds must be pre-specified. Late or missed entries are data, not something to fix by backfilling. Reconcile ePRO with EDC/IRT and review audit trails.
Worked example
A daily diary is due within 24 hours. On day 8 a patient says he forgot and asks the coordinator to enter yesterday's score. The coordinator should refuse: site entry would destroy attribution and make the record clinician-entered, not patient-reported. The correct action is to document the missed entry, check whether the system allows a late entry with its real timestamp, and retrain the patient. Do not change the device clock or recreate the entry.
Traps
Assuming a vendor's validation kit transfers all responsibility; using an unlicensed or untranslated instrument; letting site staff complete diaries; ignoring audit-trail review; treating BYOD as automatically compliant; and failing to document help-desk, training, and issue-resolution records.