SEND Blog

From TRC to CDISC CORE, the message is clear: SEND dataset quality is under scrutiny, and compliance is shifting from interpretation to automation.

With the FDA’s Technical Rejection Criteria now enforceable, avoiding automated SEND dataset rejection starts with understanding the rules, and applying them correctly.

SEND’s flexibility is both its strength and challenge; verification reveals that while quality is improving, consistency remains key to making standardized data truly usable.

SEND may seem dry to outsiders, but for those immersed in it, it’s a passion, fueling precision, efficiency, and a shared dedication to getting it right.

SEND’s flexibility allows broad adoption, but as a vendor, I can’t help wishing it were more rigid. Consistency would make tools easier to build and data easier to compare.

Despite being a standard, SEND’s flexibility means everyone does it slightly differently, making it a “subjective standard” in practice.