Patient Symptom Tracking for Clinical Trials

Patient symptom tracking for clinical trials: digital symptom and event tracking 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

Patient Symptom Tracking for Clinical Trials

Patient symptom tracking for clinical trials lets participants report symptoms and events digitally—with 21 CFR Part 11–aligned controls and one audit trail when integrated with EDC and eConsent. Common workflows include symptom diaries, event-driven reporting, and compliance monitoring. Paper and separate apps cause fragmentation and reconciliation issues. Capture provides symptom tracking and ePRO in the same platform as EDC and eConsent—one audit trail and same security.

What is patient symptom tracking and why teams want it

Patient symptom tracking captures symptom and event data from participants for clinical trials—with full audit trail. Teams want it to improve data quality and compliance. When tracking 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 symptom tracking workflows

  • Symptom and event reporting with full audit trail
  • Scheduling and 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 symptom logs: transcription errors, missing data, no single audit trail
  • Separate app or vendor: two systems, two audit trails, reconciliation
  • Participant non-compliance and fragmented data
  • Need for one platform for consent, CRFs, and symptom tracking with one audit trail

Capture approach to patient symptom tracking

  • Symptom tracking and ePRO in same platform as EDC and eConsent; one audit trail
  • PRO instruments and diaries 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 trialsPatient diary software for clinical trialsFeatures

FAQ

Questions we hear a lot

What is patient symptom tracking for clinical trials?
Patient symptom tracking lets participants report symptoms and events digitally for clinical trials—with 21 CFR Part 11–aligned controls. Capture includes symptom tracking and ePRO in the same platform as EDC and eConsent.
Do I need a separate symptom-tracking vendor?
No. Capture includes ePRO and symptom tracking. You can configure instruments and diaries; 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).

Ready to see Capture in action?

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