ePRO study guide
ePRO · Work through your exam, one topic at a time.
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. Note that this page could not verify exam logistics: the source page for this credential returned a 'Page not found' error when retrieved, so item count, duration, passing score, fee, format, retake policy, and validity period are unconfirmed here. Candidates should confirm those details directly with the certifying body before scheduling and should treat any specific figures encountered elsewhere as unverified until confirmed at the source. Topics on this exam: ePRO (electronic patient-reported outcomes). The ePRO study guide has 1 section and about 388 words.
01ePRO (electronic patient-reported outcomes)
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.
388 words, about 2 minMore study resources for ePRO
- Practice questionsIn an ePRO system, what does the term 'eDiary' most specifically refer to?
- FlashcardsePRO definition. Any patient-reported outcome collected electronically via handheld, smartphone, tablet, web, or IVR.
- Cheat sheetePRO = any patient-reported outcome collected electronically (handheld device, smartphone, tablet, web, IVR); the mode of collection does not change the underlying construct, but it must be validated as equivalent to the paper version.
- Key termselectronic patient-reported outcome (ePRO). Health data reported directly by a patient through a digital device-such as a smartphone, tablet, or web portal-without a clinician editing or interpreting the patient's entry.
- Study planDefine ePRO and distinguish it from eClinRO, eObsRO, and eDiary, writing a one-paragraph definition for each.
- Common mistakesCandidates see 'clinical trial' context in the item stem and default to the broad GCP knowledge they already have, because ePRO questions are almost always embedded in a trial scenario.
- Exam-day guideBring the original, unexpired ID in the name you registered with.