Hi Julia, Your site might find it helpful to review the FDA's draft guidance on Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices which outlines what types of deviations the FDA thinks are important (i.e. a ...

Hi all, Our site has had an ongoing conversation over the past few years over the definition of data integrity. Per ICH GCP E6(R3), data integrity means: "Data integrity includes the degree to which data fulfil key criteria of being attributable, legible, ...

Hi Tricia, Our Clinical Research Team here at Arthrex in Naples are all ACRP members and would love to connect. ------------------------------ Kelly Ganz, CCRC Clinical Research Study Manager, Principal Arthrex, INC. Naples, FL kelly.ganz@arthrex.com ...