In rare disease clinical trials, vendor management often requires a different level of coordination and adaptability compared to more traditional studies. Given the small and geographically dispersed patient populations, along with complex and highly ...

Hi Julia, Your site might find it helpful to review the FDA's draft guidance on Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices which outlines what types of deviations the FDA thinks are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