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March 21, 2024

How to Perform Clinical Trial Source Data Verification (SDV)

Performing Source Data Verification (SDV) in a clinical trial involves comparing the data recorded on the Case Report Form (CRF) or electronic equivalent (e.g., eCRF) with the original source documents to ensure accuracy, reliability, and compliance with regulatory requirements.

The aim of SDV is to look for three (3) things:

1. Data errors
2. Procedural errors
3. Fraud

Here’s a step-by-step guide on how to perform SDV:

1. Understand the Protocol: Before starting SDV, thoroughly familiarize yourself with the study protocol. Understand the inclusion/exclusion criteria, study endpoints, and procedures outlined in the protocol.
2. Training: Ensure that the personnel responsible for SDV are adequately trained on the protocol, data collection methods, and regulatory requirements. This training should include understanding the importance of SDV, identification of source documents, and the correct procedure for verification.
3. Identify Source Documents: Source documents are the original records or certified copies of original records that contain the data required by the protocol. Common source documents include medical records, laboratory reports, imaging results, and patient diaries. Clearly identify which documents serve as the source for each data point collected.
4. Develop a Plan: Develop a detailed SDV plan that outlines which data points will be verified, the frequency of verification, and the method of documentation. The plan should be consistent with regulatory requirements and sponsor expectations.
5. Perform Verification: Conduct SDV according to the plan. This involves physically comparing the data recorded on the CRF with the corresponding information in the source documents. Ensure that the data in the CRF accurately reflects what is documented in the source documents. Common data points for verification include demographic information, medical history, laboratory values, and adverse events.
6. Document Findings: Document all findings from the SDV process, including any discrepancies between the CRF and source documents. Clearly note any deviations from the protocol or issues with data quality.
7. Resolve Discrepancies: If discrepancies are identified during SDV, follow the procedures outlined in the protocol and standard operating procedures (SOPs) for resolving discrepancies. This may involve further investigation, clarification from the site personnel, or corrections to the CRF.
8. Ensure Compliance: Throughout the SDV process, ensure compliance with applicable regulatory requirements, including Good Clinical Practice (GCP) guidelines and local regulations.
9. Quality Control: Implement quality control measures to ensure the accuracy and consistency of the SDV process. This may include periodic review of SDV documentation, oversight by a quality assurance team, or independent review by a third party.
10. Final Review and Close-Out: Conduct a final review of all SDV documentation to ensure completion and accuracy. Once all SDV activities are completed, document the completion of SDV and proceed with close-out activities for the clinical trial site.

By following these steps, you can effectively perform source data verification in a clinical trial, ensuring the integrity and reliability of the trial data.

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