Sensible SEND Blog

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The pros and cons of having a flexible standard

Marc Ellison

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.

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SEND: Can a standard be subjective?

Marc Ellison

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

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The SEND Traffic Jam

Marc Ellison

In a digital world where speed is expected SEND still takes time, because quality, compliance, and subjective interpretation demand more than just pressing “convert.”

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Skeuo-what now?!

Marc Ellison

SEND sometimes mimics reported data rather than collected data – like a digital camera’s fake shutter sound mimics the real thing – raising the question of whether these “skeuomorphs” belong in our datasets or not.

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Is the world of SEND moving too fast?

Marc Ellison

March 2021 was huge for SEND – with FDA enforcing Technical Rejection Criteria, releasing new guidance, and CDISC publishing updates.

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Supported but not required by FDA – What’s the point?

Marc Ellison

“Supported but not required” isn’t just a status, it’s a warning. Now’s the time to prepare for SENDIG-DART v1.1 before it becomes mandatory.

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