How to Run Patient Diaries in Clinical Trials

How to run patient diaries in clinical trials: steps, common blockers, and tool options. ePRO with 21 CFR Part 11–aligned controls.

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

Overview

How to Run Patient Diaries in Clinical Trials

You run patient diaries in clinical trials by using ePRO in the same platform as EDC and eConsent—so diary data is captured with one audit trail and 21 CFR Part 11–aligned controls. Quick answer: use one platform that includes ePRO. Steps: define diary instruments and schedule; choose one platform for EDC, eConsent, ePRO; build study and run validation/UAT if regulated; launch. Common blockers: separate ePRO vendor, two audit trails. Tool options: look for integrated ePRO, same platform as EDC and eConsent. Capture fit: one platform for EDC, eConsent, ePRO; diaries configurable in study builder.

Quick answer and steps

Running patient diaries means ePRO in the same platform as EDC and eConsent—so diary data has one audit trail. Lead with a direct answer and numbered steps.

Steps/process

  • Define diary instruments and schedule
  • Choose one platform for EDC, eConsent, ePRO
  • Build study; configure diaries in study builder; run validation/UAT if regulated
  • Launch; diary data captured with one audit trail
  • Documentation to support sponsor validation when required (Enterprise)

Common blockers

  • Separate ePRO vendor; two audit trails and reconciliation
  • Paper diaries; no single audit trail
  • Need for one platform for consent, CRFs, and diaries with one audit trail
  • Capture: ePRO in same platform as EDC and eConsent

Tool options and Capture fit

  • One platform for EDC, eConsent, ePRO; diaries configurable in study builder
  • 21 CFR Part 11–aligned controls and HIPAA-aligned security
  • Documentation for sponsor validation (Enterprise); explore workflow or book a demo

Related

Patient diary software for clinical trialsePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

How do I run patient diaries in clinical trials?
Use one platform that includes ePRO in the same system as EDC and eConsent so diary data has one audit trail. Capture includes ePRO; explore workflow or book a demo.
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).

Ready to see Capture in action?

Explore the platform with a free sandbox. No sales call required.