ePRO study plan
ePRO · Give each week a clear focus.
8 weeks · About 6 hours per week
ePRO (electronic patient-reported outcomes)
Define ePRO and distinguish it from eClinRO, eObsRO, and eDiary, writing a one-paragraph definition for each
Map the full ePRO data flow from patient entry on a device through transmission, storage, and analysis, listing every handoff point
Identify the main device categories (handheld, tablet, smartphone, IVR, web) and state one strength and one weakness for each
Explain why paper PRO migration to electronic mode requires evidence of equivalence rather than assuming it
Your checkpoint
A one-page ePRO data-flow diagram with all handoff points annotated and a 10-term glossary of modality types
ePRO (electronic patient-reported outcomes)
Summarize the key regulatory guidance landscape for ePRO (FDA PRO guidance, EMA qualification, ICH E6 expectations for source data) without quoting text
Describe how ePRO fits into a clinical trial protocol: endpoint placement, schedule of assessments, and compliance definitions
Explain the difference between primary, secondary, and exploratory PRO endpoints and how each affects ePRO build complexity
Draft the sections of a protocol synopsis that touch ePRO
Your checkpoint
A two-page protocol synopsis excerpt covering ePRO endpoints, assessment schedule, and compliance definition
ePRO (electronic patient-reported outcomes)
Walk through instrument licensing and copyright clearance steps for a licensed questionnaire used electronically
Describe translation and linguistic validation requirements and how electronic formatting affects them
Explain cognitive debriefing and usability testing with patients before go-live
Identify what must be documented to show an electronic version preserves the validated content
Your checkpoint
A checklist of 15 items required before an instrument can go live electronically, each with the responsible role
ePRO (electronic patient-reported outcomes)
Explain 21 CFR Part 11 and Annex 11 requirements as they apply to ePRO: audit trails, e-signatures, access control, and record retention
Describe how source data are defined when a patient enters data directly, and what constitutes an audit-trail review
Map the validation approach for an ePRO system: URS, risk assessment, IQ/OQ/PQ, and traceability
Distinguish system validation from study-specific configuration testing
Your checkpoint
A validation traceability table linking five user requirements to test evidence and audit-trail review steps
ePRO (electronic patient-reported outcomes)
Design the patient-facing experience: reminders, window logic, branching, and edit rules that protect data integrity
Explain how to handle incomplete entries, out-of-window entries, and late entries without biasing results
Describe help-desk and site-support workflows, including device replacement and lost-device procedures
Plan training materials for patients, site staff, and monitors with different depth for each audience
Your checkpoint
A patient-journey map plus a one-page site quick-reference guide for handling ePRO issues
ePRO (electronic patient-reported outcomes)
Define data quality metrics for ePRO: compliance rate, timeliness, missing-item patterns, and query rates
Explain how ePRO data are reconciled with EDC and how discrepancies are resolved and documented
Describe blinded vs unblinded data handling and how to prevent unblinding through ePRO outputs
Plan the database lock sequence for ePRO, including freeze, audit-trail export, and archival
Your checkpoint
A metrics dashboard mock-up with five KPIs, target thresholds, and the action taken when each threshold is breached
ePRO (electronic patient-reported outcomes)
Connect ePRO data to analysis: scoring rules, handling of missing data, and documentation of derivation methods
Explain how to write a statistical analysis plan section describing ePRO endpoints and compliance
Describe inspection-readiness practices: what auditors request and how to retrieve it quickly
Identify common inspection findings in ePRO studies and the control that prevents each
Your checkpoint
An SAP excerpt for one ePRO endpoint plus a table of eight common findings mapped to preventive controls
ePRO (electronic patient-reported outcomes)
Synthesize the full lifecycle into a single end-to-end narrative from protocol to archive
Complete timed practice sets and review every missed item to its root cause
Rehearse explaining ePRO decisions to a non-specialist stakeholder in plain language
Close remaining gaps by re-testing the two weakest sub-areas identified in earlier weeks
Your checkpoint
A full timed mock exam with a written error log and a one-page lifecycle summary used as a final review sheet
Milestones
Week 2: Can explain ePRO modality trade-offs and the regulatory basis for electronic capture without notes, scoring at least 80% on a self-made 20-question quiz
Week 4: Can describe Part 11 controls and the validation lifecycle from memory and has a completed traceability table reviewed against the source requirements
Week 6: Can trace a single patient entry from device to analysis and explain reconciliation, unblinding protection, and lock sequence with no gaps
Week 8: Scores at or above target on the timed mock exam and has no unresolved items in the error log