How do you create a standardized model for data that drastically vary from lab to lab? Of course, I’m talking about clinical signs. When the clinical signs domain (CL) was first defined in SEND, it was clear to the modellers that every lab collects and reports clinical signs differently. So, the answer was to have …
Category Archives: Uncategorized
Still confused about the scope of SEND?
Since the FDA publicly presented clarification on the scope of SEND back in October 2020, the topic has been continually discussed and queried. The Technical Conformance Guide (TCG) was updated in September 2021 to give yet more detail and address specific areas that continue to cause confusion. It seems to me that prior to that …
Everyone is talking about it, but is anyone doing it?
It’s the thing that immediately springs to mind when we first learn that SEND and SDTM are so closely related. The idea that there may be shared databases and tools, and most importantly, the nonclinical data and clinical data could be compared. I’m guessing that anyone reading this blog will know that SEND is the …
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Thinking about the challenges facing today’s SEND newbie
I started Sensible SEND thinking back to 2012 and my initial impressions & experiences of SEND. You can read that early post here, but as a fish-out-of-water I really struggled and was completely disoriented by this new world I’d landed in. I remember thinking to myself “These people speak a different language! What’s a Tee-Pee …
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Who cares about Define files anyway?
For this week’s blog post, I thought it would be good to discuss the current use of the define.xml file within the nonclinical industry, so I’ve asked Charuta Bapat to discuss this with us as her enthusiasm for the Define-XML is bordering on infectious. Charuta works alongside me and is responsible for our define tools …
So, what did we learn from the FDA’s DART Fit For Use Pilot?
For most organizations, the FDA’s SENDIG-DART v1.1 Fit-For-Use (FFU) pilot started with the Federal Register notice being posted back in October 2020. For some of us it began earlier when it became apparent that the FDA had an appetite to adopt the SEND standard for Developmental and Reproductive Toxicology (DART). That meant a pilot was …
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Silence speaks volumes
In my last posting, we were talking about the CDISC working conference where I mentioned that one of the highlights of the week was the FDA public webcast. In the past, sometimes these have included surprising announcements which have generated a flurry of activity as we all try to digest and respond to the latest …
A week of working on 3 separate Implementation Guides
This is the week of the CDISC Spring SEND Virtual Face-to-Face meeting, and yes that’s still an oxymoron, but hopefully this will be the final time as future Face-to-Face meetings are planned to back in person again. While tee week mainly focuses CDISC volunteers on progressing the standard, one of the highlights of the event …
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In the room where it happens
For a variety of different reasons, at several times this last week, I’ve reiterated my motivations for being a CDISC volunteer. I’ve discussed how I first fell into volunteering almost accidentally, not knowing what I was getting into, and discovering I had a real passion for SEND. I’ve also been talking about the importance of …
What’s the deal with the FDA Feedback Letters?
This week I caught up with my colleague and fellow SEND obsessive, Mike Wasko. I asked him for his opinions on the FDA feedback letters that sponsors receive after IND submissions. Specifically, his thoughts on their importance and impact – Here’s what he had to say: Whenever a sponsor receives a letter or feedback from …
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