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 …
Author Archives: Marc Ellison
Can 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 …
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Latest 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, …
What is the impact of the new FDA Technical Conformance Guide?
There’s been some significant news since my last blog post. Firstly, the FDA released a new version of the study data Technical Conformance Guide (TCG), and then we had the combined CDISC and FDA public webcast where some major changes to SEND 4.0 were announced. The biggest update to the TCG was the addition of …
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It’s Sensible SEND Live! this week
I am not posting the usual written blog this week. Instead, we are having a ‘Sensible SEND Live!’ event on Thursday 13th April, at: If you would like to attend, but have not registered already, please use this link: https://register.gotowebinar.com/register/7321181066406386262 The event will be a live blog style presentation followed by a time for Q&A …
SEND @SOT 2023: Same, but different
After my 4 years away, I finally got a Society of Toxicology (SOT) meeting in person again, and while much of it felt familiar, I was surprised by just how different some things were: How much our industry has moved on in those 4 COVID-impacted years. The event felt like it was numerically back to …
Is there really that much to say about SEND?
Back in 2020 when the idea of blogging about SEND was first suggested to me, my initial thought was “What is there to talk about?”. This is now my 61st bi-weekly post. If you have been with me along that journey, then you will have spotted a few recurring themes. I like discussing scope, future …
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Who uses the CoDEx document anyway?
Recently the question was asked “Are bone length measurements in scope for SEND?”, which leads to another interesting question: “Who gets to decide what is in scope for SEND?”. There are two parts to this. Firstly, which data were intended to be covered by the various CDISC documents, and secondly, which data do FDA require …
Are you ready for a tighter standard?
From my earliest introductions to SEND, one of the things that surprised me most was just how loose it was. It seemed that at every turn there were choices. The phrase “The sponsor chose…” occurs throughout the implementation guide when describing a particular representation of data. Several years ago, I was presenting at the Society …
How creative should we be with SEND?
Recently, more and more, I’m being asked my opinion about the scope of SEND and if a certain study or even a certain endpoint should be provided in SEND. Clearly, I’m referring to data which do not have an obvious example in the SEND IG. However, the lack of example cannot be the defining criteria …
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