ePRO for Academic Clinical Studies

ePRO for academic clinical studies: patient-reported outcomes with 21 CFR Part 11–aligned controls. Lean teams, budget sensitivity, investigator-led workflows.

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

Overview

ePRO for Academic Clinical Studies

ePRO for academic clinical studies supports investigator-led and academic trials: patient-reported outcomes with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Academic studies often have lean teams, budget sensitivity, and investigator-led workflows—they need one platform without enterprise ePRO pricing or separate vendors. Paper and app fragmentation cause issues. Capture provides ePRO in the same platform as EDC and eConsent—one audit trail, built for academic and investigator-led use.

Why academic studies want ePRO

Academic and investigator-led studies need participant-reported data with full audit trail and 21 CFR Part 11–aligned controls—with lean teams, budget sensitivity, and investigator-led workflows. 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 academic 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 investigator-led workflows
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Pricing and support that fit lean teams and academic budgets
  • 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, cost and complexity for lean teams
  • Enterprise ePRO minimums that don’t fit academic budgets
  • Need for one platform for consent, CRFs, and ePRO with one audit trail

Capture approach to ePRO for academic studies

  • ePRO in same platform as EDC and eConsent; one audit trail; fit for academic and investigator-led use
  • 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

EDC for academic clinical trialsePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is ePRO for academic clinical studies?
ePRO for academic studies lets you collect patient-reported outcomes in investigator-led or academic trials—with 21 CFR Part 11–aligned controls. Capture includes ePRO in the same platform as EDC and eConsent, with fit for lean teams and academic workflows.
Do I need a separate ePRO vendor for academic 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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