Compliance with SEND is crucial, but correctness is king. A perfectly formatted dataset means little if the values don’t reflect the actual study data.
SEND works well for single study review, but variability across datasets limits its value for cross-study analysis, something the JPMA’s recent paper explores in compelling detail.
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.
