ePRO key terms

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.

Any measurement of a patient's health status, symptoms, or functioning that comes straight from the patient rather than from a clinician or laboratory test.

A structured log in which participants record symptoms, medication use, or events at set times; in ePRO it is completed on an electronic device instead of paper.

The principle that patients type or tap their responses straight into the ePRO system, with no member of the site staff transcribing or altering the data afterward.

The hardware a participant uses to answer questionnaires, such as a provisioned smartphone, tablet, or interactive voice response phone system; it must be validated and configured for the trial.

A device supplied and controlled by the study sponsor, locked down to the ePRO application, so that all participants use identical hardware and software.

A model in which participants use their personal phone or tablet to complete ePRO questionnaires, with the study application installed and managed remotely.

Software installed on a phone or tablet that presents questionnaires, sends reminders, and transmits responses to the study database, often working offline until connectivity returns.

A telephone-based system where participants answer questionnaires by pressing keys or speaking in response to recorded prompts, useful for people without smartphones or internet access.

A browser-based system through which participants complete ePRO questionnaires and site staff may manage schedules, distinct from telephone-based interactive voice response.

The umbrella category for outcomes captured electronically, including ePRO, clinician-reported, observer-reported, and performance outcomes collected on digital devices.

An assessment of a patient's condition made by a trained health professional, such as a rating scale score, which may be collected electronically alongside ePRO in the same system.

A measure reported by someone other than the patient, such as a parent or caregiver, used when the patient cannot self-report, for example in young children or cognitive impairment.

A patient's perceived physical, emotional, and social well-being as affected by illness and treatment, commonly measured with ePRO instruments in trials.

The questionnaire or instrument itself-its items, response options, and scoring rules-used to quantify a PRO concept in a defined population.

A validated set of questions with defined wording, response scales, recall period, and scoring algorithm that produces a numeric score for a PRO concept.

The time frame a question asks the patient to think about, such as the past 24 hours or past 7 days; it drives how often the questionnaire must be completed.

The body of evidence-reliability, validity, responsiveness, and interpretability-showing that an instrument measures its intended concept accurately and consistently in a given population.

The smallest change in a PRO score that patients would regard as meaningful, used to interpret whether an observed treatment effect matters in practice.

The proportion of expected ePRO entries a participant actually completes on time, a key data-quality metric reported by site and by participant.

The permitted time span around a scheduled assessment within which an entry still counts as on time, balancing data quality against realistic patient behavior.

An automated alert-push notification, text message, email, or phone call-prompting a participant to complete a due questionnaire before the compliance window closes.

A message the ePRO app displays on a device without the user opening it, typically used to signal that a questionnaire is now due.

The system-recorded date and time of each ePRO entry, used to confirm when data were captured and whether they fall inside the compliance window.

A secure, computer-generated record of who created, modified, or viewed ePRO data and when, required to demonstrate data integrity and regulatory compliance.

The US FDA regulation setting requirements for electronic records and electronic signatures, covering access control, audit trails, and system validation for ePRO systems.

Documented evidence that an ePRO system performs as intended and consistently, produced through a risk-based process of planning, testing, and formal release.

Testing in which intended users confirm that the configured ePRO system supports real study workflows-screening, scheduling, and data review-before go-live.

The property that ePRO data are complete, accurate, attributable, legible, contemporaneous, original, and unaltered throughout their lifecycle, often summarized by the ALCOA+ principles.

The original records from which study data are derived; for ePRO, the patient's own electronic entry in the device or system is typically the source.

Any original record-including an ePRO entry, clinic note, or printout-that supports the existence of a data point and may be inspected during monitoring.

Capturing trial data electronically at the point of origin so the electronic record itself serves as the source, reducing transcription and reconciliation burden.

The clinical database system into which site staff enter case report form data; ePRO responses are usually transferred or integrated into it for analysis.

The scheduled, validated movement of ePRO data from the vendor platform into the sponsor's clinical database, governed by agreed specifications and reconciliation checks.

The process of comparing ePRO records against other trial data sources to identify and resolve discrepancies, such as missing entries or mismatched visit dates.

A formal request for clarification or correction of data, raised by monitors or data managers and resolved by the site with documentation of the outcome.

The support service participants and site staff contact for device problems, forgotten passwords, or technical issues, with contacts logged and tracked to resolution.

Structured instruction that site staff receive on enrolling participants, issuing devices, and monitoring compliance so that ePRO procedures are performed consistently.

Education given to participants on how to use the device, when to complete questionnaires, and whom to contact for help, ideally documented at enrollment.