What Do Auditors Look for When Performing SDV and SDR?

Meghan Hosely
September 10th, 2020

Keeping subjects safe and data reliable as a protocol moves through its phases is of the utmost importance in clinical research. Source data review (SDR) and source data verification (SDV) are used during routine investigator site audits. Auditors use SDR when reviewing the source documentation to check on quality, protocol, and good clinical practice (GCP) compliance, staff involvement, and other areas not associated with a case report form (CRF). Conversely, SDV is used to compare data within the CRF/eCRF to the original source of information – and vice versa – to confirm accurate data transcription. This blog outlines how to ensure your next site audit goes smoothly while contributing quality data to move research forward.

To learn more, read the full article on Advarra’s website.

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