ePRO case studies
ePRO · Put your knowledge to work in context.
The ePRO Certification is presented on this page as a credential in electronic patient-reported outcomes, a domain that sits at the intersection of clinical data management, clinical trial operations, and patient-facing digital technology. It is intended for professionals who work with patient-reported outcome data collected electronically - including clinical data managers, clinical programmers, site and study coordinators, and quality or compliance staff who review ePRO data flows. The exam domain covers ePRO as a single topic area, meaning candidates should expect questions spanning the full ePRO lifecycle: instrument selection and licensing, device and platform configuration, patient training and usability, data transmission and audit trails, edit-check and discrepancy handling, and inspection readiness. Preparation should combine a working knowledge of the clinical data management processes around ePRO with hands-on familiarity with how ePRO systems capture, transmit, and reconcile patient-entered data against the clinical database. The ePRO case studies are 5 cases and about 3,386 words.
1Weekly Diary, Shared Phones, and a Mid-Study Device Decision
An open-label phase 3 non-small cell lung cancer trial enrolls 62 participants across 14 sites in three countries. The protocol specifies a nine-item weekly ePRO diary completed on a provisioned Android tablet between Sunday 18:00 and 23:59 local time.
696 words, about 3 min2Electronic Migration of a 24-Hour Recall Scale
A phase 2 rheumatoid arthritis trial plans to use a 12-item symptom scale with a 24-hour recall and 0–10 numeric rating scales. The paper version has published psychometric support.
726 words, about 4 min3The Site With 45% Compliance
A migraine prevention trial uses a daily two-item ePRO diary: migraine occurrence yes/no and worst pain 0–10. The diary opens at 06:00 and must be completed by 10:00 for the previous 24 hours.
642 words, about 3 min4Android Update, Offline Cache, and the Paper Backfill Request
A multicenter asthma trial uses an ePRO app for a daily morning symptom diary. The app caches entries offline and syncs when connectivity returns.
639 words, about 3 min5Adolescent Self-Report, Proxy Consent, and a Safety Alert
A phase 3 adolescent asthma trial enrolls participants aged 12–17. The daily ePRO diary includes asthma symptoms and a weekly mood item scored 0–3.
683 words, about 3 min