What it is
Source Data Verification (SDV) is the process of confirming that data entered in the EDC matches original source documents (hospital records, lab reports, etc.). In ClinicalDataS, SDV is delivered as an installed study app that defines what must be verified and provides worklists for monitors and authorized reviewers.
Who uses it
| Role | Typical use |
|---|---|
| CRA / Monitor | Perform SDV on assigned CRF fields and events |
| Study Administrator | Configure SDV scope, percentage rules, and recipients |
| Data Manager | Track SDV completion rates and outstanding items |
| Investigator | Review SDV status on subject records |
Key capabilities
- Configurable SDV scope by form, field, event, or percentage targeting
- Item-Level SDV — target specific fields within a CRF for partial verification
- SDV Events worklist grouped by study event or CRF view
- Integration with Monitoring Visit reporting
- Options for SDV when queries are open or CRFs are not yet verified
- Mobile SDV — perform verification on iOS/Android via CDS Staff App
- Full audit trail — every SDV action is recorded with who, when, and what
SDV Modes
| Mode | What gets verified | Use case |
|---|---|---|
| CRF-Level SDV | Entire CRF (all fields) | Standard verification, high-risk studies |
| Item-Level SDV | Specific fields only (Partial Required) | Risk-based monitoring, targeted verification |
| Subject-Level SDV | Entire subject (all CRFs across all events) | Final sign-off, regulatory readiness |
Item-Level SDV
When a CRF is configured with SDV Requirement = Partial Required, only designated items need verification. This enables risk-based monitoring where only critical data points (e.g., primary endpoint, safety data) are verified.
- Only marked items show Unverified/Verified buttons
- CRF auto-promotes to Verified when all required items are done
- Cannot bulk-verify the entire CRF — each item must be individually verified
Mobile SDV
SDV can be performed on the CDS Staff Mobile App (iOS/Android) when the study has mobile SDV enabled.
- Same verification workflow as web
- Requires network connectivity (not available offline)
- All SDV actions sync in real-time with the server
Audit Trail
Every SDV action is recorded with full traceability:
- Who performed the verification
- When (timestamp with timezone)
- What was verified (CRF, subject, or specific items)
- Before/After status changes
Audit trail is accessible from the Subject Casebook and the SDV Events page.