How to Document Source Data Verification (SDV) in Monitoring Reports
Best Practices for Documenting SDV in Clinical Monitoring Reports Source Data Verification (SDV) is a core function of clinical monitoring. However, even perfectly executed SDV can lose its value if not appropriately documented in the Monitoring Visit Report (MVR). Regulatory authorities such as the USFDA and CDSCO emphasize that proper documentation of SDV activities is…
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