Source Data Verification (SDV) Process

Ensuring Data Accuracy, Integrity & Regulatory Compliance

At CMPV Consultancy LLP, our Source Data Verification (SDV) process is designed to ensure the accuracy, completeness, consistency, and traceability of safety and clinical data across pharmacovigilance and clinical operations. SDV plays a critical role in maintaining data integrity, supporting regulatory submissions, and ensuring patient safety.

Our structured, risk-based SDV approach complies with ICH-GCP (E6 R2/R3), EU GVP, CDSCO, US FDA, and global regulatory inspection requirements.

What is Source Data Verification?

Source Data Verification is the systematic comparison of source documents (e.g., medical records, laboratory reports, case report forms, safety databases) with reported data to confirm that information is:

Accurate
Complete
Consistent
Timely
Traceable to original records

CMPV Consultancy LLP – SDV Approach

We follow a risk-based, audit-ready SDV methodology tailored to sponsor, CRO, and marketing authorization holder (MAH) requirements.

1. SDV Planning & Scope Definition

Review of protocol, safety management plans, SOPs, and data flow
Identification of critical data points (SAEs, AESIs, endpoints)
Determination of SDV intensity (100% or targeted/risk-based)
Development of SDV plan and checklist

2. Source Document Review

Verification of source documents including:
- Medical records and case notes
- Laboratory and diagnostic reports
- Informed consent forms
- Adverse event and SAE documentation
Confirmation of document authenticity, legibility, and completeness

3. Data Comparison & Verification

Cross-checking source data against:
- Case Report Forms (CRFs/eCRFs)
- Safety databases (Argus, ArisG, etc.)
- Line listings and narratives
Verification of:
- Event onset and resolution dates
- Seriousness, severity, causality
- Concomitant medications and medical history

4. Query Identification & Resolution

Identification of discrepancies, missing data, or inconsistencies
Generation of data clarification queries
Coordination with site, sponsor, or safety teams for resolution
Documentation of query closure and justification

5. Documentation & Traceability

Maintenance of SDV logs and evidence trails
Verification of audit trail entries
Confirmation of data version control and change history
Ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)

6. SDV Reporting & Compliance Review

Preparation of detailed SDV reports including:
- Observations and findings
- Risk classification
- Corrective and preventive action (CAPA) recommendations
Readiness support for regulatory inspections and audits

Key Benefits of CMPV’s SDV Services

✔ Improved data quality and reliability
✔ Reduced regulatory and inspection risk
✔ Early detection of data gaps and compliance issues
✔ Support for pharmacovigilance audits and submissions
✔ Enhanced confidence in safety signal evaluation

Applicable Regulatory Standards

ICH-GCP E6 (R2/R3)
EU GVP Modules
US FDA 21 CFR Part 11
CDSCO & DCGI requirements
ISO-aligned quality systems

Why Choose CMPV Consultancy LLP?

Experienced pharmacovigilance and clinical QA professionals
Risk-based and inspection-ready SDV methodology
Remote and on-site SDV support
Customized solutions for sponsors, CROs, and MAHs
Strong focus on data integrity and patient safety

Contact Us

If you are looking for reliable, compliant, and efficient Source Data Verification services, CMPV Consultancy LLPis your trusted partner.

📧 Email: cmpvconsultancy@gmail.com
🌐 Website: http://www.cmpv.in

Contact us today to strengthen your data integrity and regulatory compliance.