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
- 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