Source Document Verification Built Into the Study Record
The Trialhelix SDV workflow gives CRAs a structured process for documenting SDV completions, generating queries from discrepancies, and producing monitoring visit reports — all within the same audit trail as the clinical data.
Site Monitoring Procedure in Trialhelix
Visit Planning
The CRA reviews the site's open queries, SDV completion status, and data entry completeness before the monitoring visit. Trialhelix generates a pre-visit report showing which data items are flagged for review.
SDV Completion Recording
During the visit, the CRA marks each eCRF field as SDV-complete against the source document. SDV status is recorded at the field level — not just at the form level — enabling granular completion reporting and RBM compliance documentation.
Discrepancy Query Generation
Where the CRA finds a discrepancy between source and eCRF data during SDV, a query is generated directly from the SDV interface — linked to the specific field, visit, and subject. The query is routed to the site coordinator automatically.
Monitoring Visit Report
After the visit, the CRA generates the monitoring visit report from the structured data recorded during the visit — SDV completion summary, queries raised and resolved, protocol deviations identified, and follow-up action items. The report is attached to the audit trail.
Follow-Up Tracking
Action items from the monitoring visit report are tracked to closure. The CDM lead and CRA can see outstanding follow-ups per site on the study dashboard — visible to the sponsor observer role without needing a status update email.
RBM-Compatible SDV Workflow
ICH-GCP E6(R2) introduced risk-based monitoring as an accepted alternative to 100% SDV. Many Phase I and II studies now use a targeted SDV approach — 100% SDV for critical data elements, statistical sampling for non-critical data.
Trialhelix supports this with configurable SDV plans per study: define which data categories require 100% SDV, which use a specified percentage, and which are centrally monitored only. SDV completion reporting reflects the RBM plan thresholds — not a binary 0/100% metric.
- Critical data SDV plan configurable per protocol safety category
- Statistical sampling SDV with audit-log of selected subjects/visits
- Centralized monitoring signal reports for remote SDV planning
- RBM completion percentage visible in real time to CDM and sponsor
See the Site Monitoring Workflow
A 30-minute call can demonstrate the SDV interface, RBM plan configuration, and monitoring visit report generation — with a sample study similar to your Phase.