Intel, insight and opinions from SEND Specialist (Nerd), Marc Ellison
Welcome to Sensible SEND
We hope you’ll bookmark the blog and check back often. Look for new posts every other Wednesday offering insights and expert opinions to help you navigate the challenges and opportunities that arise from the SEND standard.
The symbiotic relationship between the SEND Implementation Guide and the FDA’s Technical Conformance Guide
In theory, the relationship between CDISC’s SEND Implementation Guide (IG) and the FDA’s study data Technical Conformance Guide (TCG) is pretty straight forward: CDISC defines the IG and then the TCG communicates “general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog” (section 1.1). The…
Read moreCan we make cheaper, faster SEND without compromising quality?
Recently, I asked one of our Senior Information Scientists, “If a customer asked you what they could do to make data easier to convert to SEND, what would you say?” Honestly, I was expecting maybe two or three bullet points of slightly vague suggestions. What I got was about three pages of very specific and…
Read moreLatest updates on SEND v4.0
This week’s blog will cut straight to the chase: The scope of SEND 4.0 has significantly increased of late, and so the timeline has been impacted too. That means in the next update to the main Implementation Guide, we are getting 8 new domains: Since my introduction to SEND back in the SEND 3.0 days,…
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