trial-related subject records

Time-limited access that expires post-visit

Maintaining an EMR access log at the site

Access policies must be documented in the site monitoring SOP and agreed upon during the site initiation visit. Templates are often available from Pharma SOP templates.

Preparing for EMR-Based SDV

1. Obtain the EMR navigation guide or training from site staff
2. List required data points per subject from CRF (e.g., AE dates, vitals, consent dates)
3. Coordinate with the site to preload patient charts for quick access

Steps to Perform SDV in EMR Systems

Step 1: Locate the Right Subject

Use anonymized subject IDs or site-specific trial enrollment codes to identify records. Avoid accessing unrelated patient records.

Step 2: Navigate to Relevant Modules

• Progress Notes – Verify eligibility and AE documentation
• Lab Results – Match lab values to protocol timelines
• Prescriptions – Cross-check investigational product (IP) dispensing
• Consent Forms – Confirm correct version and signing date

Step 3: Record Discrepancies

Document findings in the site SDV log or query forms. Ensure discrepancies are recorded without transcribing PHI.

Step 4: Exit and Log Out

Close all open records and log out from the EMR system. Confirm session termination with the site’s IT or coordinator.

Ensuring Privacy and Confidentiality

When performing SDV in EMRs:

• Do not copy or photograph the screen
• Avoid writing down names, MRNs, or other identifiers
• Summarize verification (e.g., “AE onset date confirmed”)
• Use secure CTMS for SDV logs and findings

For more on privacy protocols, refer to Stability Studies and their guidance on source data confidentiality.

Documenting EMR SDV in Monitoring Reports

Monitoring Visit Reports should clearly describe:

• Which subjects and visits were verified via EMR
• Which modules were accessed (labs, notes, etc.)
• Any system access issues or delays
• Whether documentation was adequate and discrepancies resolved

Audit Trails and Compliance

Most EMR systems generate logs showing access time, user ID, and patient chart viewed. CRAs should ensure:

• Access logs are stored at the site
• They do not delete or alter audit data
• Site confirms EMR audit logs are retrievable for inspections

Training CRAs for EMR Use

Organizations should train monitors on:

• Navigation of common EMR platforms (Epic, Cerner, Meditech)
• Data retrieval specific to clinical protocols
• Privacy compliance, redaction, and audit requirements

Integration with Risk-Based Monitoring

For trials following risk-based monitoring models, SDV in EMRs should be tailored based on critical data points. Full verification may be limited to eligibility, consent, AEs, and primary endpoint data.

Conclusion

Source Data Verification within EMR systems is now a standard aspect of modern clinical trials. By following structured access protocols, maintaining subject privacy, and documenting thoroughly, CRAs can perform SDV effectively while ensuring full compliance with regulatory and GCP expectations. A clear SOP and template-based approach will help maintain consistency across sites and monitors.