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Source Data Verification (SDV)

What is Source Data Verification (SDV)? Source data verification (SDV) is the process by which the reported information is compared with the original source records. SDV is usually done by sponsor personnel or those representing the sponsor.

Why is SDV useful for clinical trials?

Source data verification is useful to:

  • Confirm the completeness, accuracy, and completeness of the data submitted.
  • Ensure that the data matches the patient’s medical records.
  • Identify any deviations from the protocol.
  • Prevent further errors

How has the SDV process changed?

Historically, SDV was done for all data, and usually through site visits. Now, even recommendations from the FDA suggest that random and automated SDV can be done to increase the efficiency of the process as SDV alone cannot guarantee that the data will be error-free. SDV has also been included in the central monitoring process to increase efficiency.

Source: The Role of Source Data Verification (SDV) and Source Data Review (SDR) in Driving Clinical Trial Data Quality. (2022, February 16). Medidata Solutions. Retrieved July 16, 2022, from https://www.medidata.com/en/life-science-resources/medidata-blog/providing-clarity-on-the-definitions-of-source-data-verification-sdv-and-source-data-review-sdr