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.
March 2021 was huge for SEND – with FDA enforcing Technical Rejection Criteria, releasing new guidance, and CDISC publishing updates.
“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.
The FDA’s surprise Federal Register Notice makes SENDIG-DART officially accepted, and required from March 2023. For those of us who’ve championed it, it’s a long-awaited and exciting milestone.
Standardized SEND data is unlocking the power of visualization, enabling faster, clearer insights and opening the door to a future beyond static PDFs.
While many still struggle with SEND, a few are venturing Beyond Compliance, unlocking insights from standardized data with tools like SEND Explorer and breathing new life into legacy studies.
