Guest Column

Is The SDV In Risk-Based Monitoring Misunderstood?

Laurie Meehan

By Laurie Meehan, Polaris Compliance Consultants

What’s in a name?  Not much according to Shakespeare.  But the man who penned “A rose by any other name would smell as sweet” was a 16th century poet and playwright, not a 21st century clinical research professional.  For us, names matter.  Despite recent efforts to standardize the definition of Source Data Verification (SDV), the term still means different things to different people, and that needs to be navigated very carefully.