Is The SDV In Risk-Based Monitoring Misunderstood?

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 16^th century poet and playwright, not a 21^st 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.