ePRO flashcards

33 cards. Read the term and the definition here. The deck at the top of this page is optional.

ePRO definition

Any patient-reported outcome collected electronically via handheld, smartphone, tablet, web, or IVR. The mode does not change the construct, but it must be validated as equivalent to the paper version.

PRO instrument fitness for purpose

Documented content validity in the target population, psychometric evidence (reliability, construct validity, responsiveness), and a prespecified endpoint definition in the protocol before first patient in.

Minimally important difference

The smallest change in a PRO score that patients perceive as beneficial. It must be stated a priori and tied to an anchor or distribution-based method; statistical significance without clinical relevance does not support labeling.

21 CFR Part 11

US regulation governing electronic records and signatures. It requires audit trails, secure time-stamped records, access control, and validated systems for ePRO data used in regulatory submissions.

EU Annex 11

EU GMP annex on computerized systems. It requires risk-based validation, audit trails, access control, and documented change control for ePRO systems used in clinical trials.

IEC 62366 usability validation

Standard for applying human factors engineering to medical devices and systems. Summative testing must include the intended patient population, including low-literacy, elderly, and visually impaired users.

Screen equivalence

Each ePRO item must render fully on one screen without scrolling. Visual analog scales and complex grids need specific justification or redesign for small screens.

Audit trail requirements

The ePRO system must capture a timestamp for each entry, prevent back-filling, and store an immutable audit trail. Sponsor edits must be logged with reason and user ID.

BYOD in ePRO

Bring-your-own-device collection requires a validated app, a device compatibility matrix, a plan for OS updates, and documented equivalence testing when mixed devices are used.

ePRO source data

Entries made directly by the patient are source data. Site transcription into the EDC creates a second source and must be reconciled with an audit trail.

Instrument licensing

Copyrighted PRO instruments such as EORTC, FACIT, and SF-36 require a license. Electronic migration often requires a separate e-license and validated translations.

Entry compliance

The proportion of expected ePRO entries that are completed. It should be prespecified and monitored by arm to detect differential compliance that could bias results.

Diary recall period

The time frame an instrument asks patients to remember, such as 24 hours for a daily diary. Entries outside the allowed window are excluded per a prespecified rule, not ad hoc.

ICH E9(R1) estimand

A framework requiring specification of how intercurrent events such as treatment discontinuation or device failure are handled. Complete-case analysis alone is rarely acceptable for PRO endpoints.

MMRM for PRO analysis

Mixed models for repeated measures are commonly used for PRO endpoints. The choice must match the estimand and the missing-data assumption specified in the statistical analysis plan.

Device malfunction reporting

Device malfunctions that affect data should be reported as protocol deviations. A documented tiered help-desk support model with response times is expected.

Centralized compliance monitoring

Review of compliance dashboards, site-level outlier detection, and risk-based monitoring per ICH E6(R2). Differential reminder strategies across arms can bias PRO results and must be avoided.

Paper-to-electronic migration

Requires cognitive debriefing and, where feasible, an equivalence study comparing paper and ePRO administration in the target population, documented in a migration report.

Differential item functioning

A formal test of measurement equivalence across modes. Supporting evidence includes similar means, variances, and item-total correlations between paper and electronic administration.

ISPOR translation good practices

Forward and back translation, reconciliation, cognitive debriefing, and harmonization across languages for PRO instruments used in multinational ePRO trials.

WCAG 2.1 AA accessibility

Accessibility standard relevant to patient-facing apps in many jurisdictions. Font size, contrast, and screen reader support must be validated with the intended population.

Decentralized trial ePRO logistics

Direct-to-patient device shipping requires chain-of-custody, condition checks, and a documented return and decommissioning process, plus a fallback for patients without smartphones.

eConsent validation

Electronic consent platforms must meet Part 11 and GDPR requirements and be validated. ePRO training can be delivered remotely with documented competency.

ePRO safety alert thresholds

The protocol must define alert thresholds for safety-relevant symptoms such as suicidal ideation or severe pain, with a same-day escalation pathway to the site or medical monitor.

Alert fatigue

A known failure mode in ePRO safety systems. Automated alerts must be validated and tested, with documented review of false positives and false negatives.

DSMB ePRO review

The DSMB charter should specify what ePRO symptom summaries are reviewed and how often, supporting aggregate signal detection during the trial.

GAMP 5 computer system validation

A risk-based validation approach with IQ/OQ/PQ and a validation summary report. ePRO systems are typically GAMP category 4 or 5.

Vendor qualification

Review of the vendor quality management system (ISO 9001/27001), validation documentation, and reference checks. The sponsor remains accountable for data integrity.

Data transfer specification

Defines file formats, frequency, encryption, reconciliation process, and error handling between the ePRO vendor and sponsor, supporting auditable data flow into the EDC.

PRO labeling claim

A PRO result intended for labeling must be prespecified, clinically meaningful, and supported by a validated instrument with a documented MID.

CONSORT PRO extension

Reporting guidance for PRO results in trial publications. It supports transparency and reduces selective reporting of PRO endpoints.

ePRO governance team

A cross-functional group (clinical, data management, regulatory, IT, quality) that owns standards, vendor strategy, and change control for ePRO across trials.

ePRO quality metrics

Compliance rate, timeliness, help-desk ticket volume, deviation rate, and data query rate should be tracked and trended to detect systematic issues.