ePRO for Observational Studies

ePRO for observational studies: patient-reported outcomes with 21 CFR Part 11–aligned controls. Integrated with EDC and eConsent.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Overview

ePRO for Observational Studies

ePRO for observational studies lets you collect patient-reported outcomes in registries and observational research—questionnaires, diaries, symptom tracking—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Observational studies often rely heavily on PRO data; one platform for consent and ePRO simplifies compliance and data quality. Paper and app fragmentation cause issues. Capture provides ePRO in the same platform as EDC and eConsent—one audit trail and same security.

Why observational studies want ePRO

Observational studies need participant-reported data with full audit trail and 21 CFR Part 11–aligned controls—often with long follow-up and repeated assessments. When ePRO is in the same platform as EDC and eConsent, you get one build and one audit trail; when it’s separate, you get integration cost and two audit trails.

Common ePRO workflows for observational studies

  • Schedule PRO instruments by visit or time window; same platform as CRFs and consent
  • Capture patient-reported data with full audit trail; support for long follow-up
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Query and export for analysis and publication or regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

Why paper and app fragmentation cause issues

  • Paper PROs: transcription errors, missing data, no single audit trail
  • Separate ePRO vendor: two systems, two audit trails, integration and reconciliation
  • Long observational follow-up with fragmented data across systems
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO for observational studies

  • ePRO in same platform as EDC and eConsent; one audit trail
  • Questionnaires, diaries, and PRO instruments configurable in study builder
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore ePRO or book a demo

Related

ePRO software for clinical trialsEDC for observational studiesFeatures

FAQ

Questions we hear a lot

What is ePRO for observational studies?
ePRO for observational studies lets you collect patient-reported outcomes in registries and observational research—with 21 CFR Part 11–aligned controls. Capture includes ePRO in the same platform as EDC and eConsent.
Do I need a separate ePRO vendor for observational studies?
No. Capture includes ePRO. You can configure and schedule PRO instruments; data is captured with the same audit trail and security controls as the rest of the study.
Is Capture 21 CFR Part 11–aligned?
Yes. Capture is designed with 21 CFR Part 11–aligned controls and HIPAA-aligned security. We provide documentation to support sponsor validation when required (Enterprise).

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