Verify the data that matters, not every field
Mark which fields need source data verification, change it as risk changes, and let monitors spend their visits where it counts. Every configuration change is versioned with a reason.
- SDV set per field
- Versioned with reasons
- Site risk monitor
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- Date of birth
- Systolic blood pressure
- Diastolic blood pressure
- BMI (calculated)never verified
- Position during measurement
- Comments
Changed by Data manager · reason: critical safety value added
Per field
SDV requirement, including table columns
v1, v2, v3
every SDV change versioned
0
new form versions needed to change SDV
RAG
site risk status on the dashboard
Targeted SDV
A critical-data set you can change mid-study
Tick the fields that need verification on each form. The set can change after approval without a new form version, and each save creates a new SDV configuration version with a reason and a per-field audit entry.
- One checkbox per field, and per column for table forms.
- Calculated fields excluded automatically.
- "SDV: x of y fields" summary with mark-all and clear-all.
- Past verifications kept in the history when a field drops out of scope.
- Date of birth
- Systolic blood pressure
- Diastolic blood pressure
- BMI (calculated)never verified
- Position during measurement
- Comments
Changed by Data manager · reason: critical safety value added
Monitor workflow
Monitors see only what they need to verify
Only fields in the critical set show an SDV marker. Monitors verify field by field or verify all on a form, then submit the verification in one step.
- Verify all, then submit verification.
- SDV progress counts only fields in scope.
- Queries raised in context from the field.
- Freeze and lock remain available to data managers on every field.
Central monitoring
Know which sites need attention
The site risk monitor rates each site red, amber or green and says why, such as SAEs pending review. Compliance and overdue work are tracked alongside.
- Site risk monitor with the reason behind each rating.
- Site compliance and overdue tasks.
- Out-of-window visits flagged, with optional automatic queries.
- Critical-to-quality factors and quality tolerance limits defined for the study.
Build a risk-based SDV plan today
Mark your critical fields on a sample study in a free sandbox.
The difference
100% SDV vs risk-based SDV in Capture
What is risk-based monitoring?
An approach, encouraged by ICH E6(R3), that focuses monitoring on the data and processes most critical to participant safety and result reliability instead of checking everything equally.
How do I choose which fields need SDV?
Tick the SDV checkbox next to each critical field in the form. The set can be updated later, with a reason, as risk changes.
Does changing SDV require a new form version?
No. SDV settings change independently of the form, creating a new SDV configuration version instead.
What happens to verifications already done?
They stay in the audit trail and history. A field removed from scope simply stops showing the SDV marker and counting towards progress.
How is site risk shown?
The dashboard site risk monitor rates each site red, amber or green with the reason, for example SAEs pending review.
Can I define quality tolerance limits?
Yes. Critical-to-quality factors and quality tolerance limits can be defined for the study.
Are out-of-window visits flagged?
Yes. Optional badges flag overdue and out-of-window visits, and an automatic query can be raised when a visit date falls outside its window.
Can I try it?
Yes. The free sandbox includes SDV configuration and the monitor workflow.
Keep exploring
Related pages
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