Digital Patient Diary for Clinical Studies

Digital patient diary for clinical studies: collect patient-reported data 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

Digital Patient Diary for Clinical Studies

A digital patient diary for clinical studies lets participants record symptoms, events, and daily data electronically—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Common workflows include daily or event-driven entries, symptom tracking, and compliance monitoring. Paper and app fragmentation cause issues: multiple systems and no single audit trail. Capture provides digital diary and ePRO in the same platform as EDC and eConsent—one audit trail and same security.

What is a digital patient diary and why teams want it

A digital patient diary captures daily or event-driven patient-reported data for clinical studies—symptoms, events, adherence—with full audit trail. Teams want it to improve data quality and compliance. When the diary is in the same platform as EDC and eConsent, you get one audit trail; when it’s separate, you get integration cost and two audit trails.

Common digital diary workflows

  • Daily or event-driven diary entries with full audit trail
  • Symptom and event tracking; compliance monitoring
  • Same 21 CFR Part 11–aligned controls and HIPAA-aligned security as EDC and eConsent
  • Query and export for analysis and regulatory use
  • Documentation to support sponsor validation when required (Enterprise)

Why paper and app fragmentation cause issues

  • Paper diaries: transcription errors, missing data, no single audit trail
  • Separate diary app or vendor: two systems, two audit trails, reconciliation
  • Participant non-compliance and fragmented data
  • Need for one platform for consent, CRFs, and digital diary with one audit trail

Capture approach to digital patient diary

  • Digital diary and ePRO in same platform as EDC and eConsent; one audit trail
  • 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

Patient diary software for clinical trialsePRO software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is a digital patient diary for clinical studies?
A digital patient diary lets participants record daily or event-driven data electronically for clinical studies—with 21 CFR Part 11–aligned controls. Capture includes diary and ePRO in the same platform as EDC and eConsent.
Do I need a separate diary vendor?
No. Capture includes digital diary and ePRO. You can configure diaries and 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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