Spoiler Warning: This week’s blog post is even more self-indulgent than usual. I’m recognizing two very significant anniversaries in my professional career. This month marks 25 years of working in the nonclinical space. September 1997 saw me take a programming job at a preclinical software vendor, fully in the expectation that it would be a …
Author Archives: Marc Ellison
New standards on review
The CDISC SEND team have several new standards edging their way towards publication. The SENDIG-Genetox is the CDISC SEND standard for the representation of in vivo genetic toxicology studies. This has completed an internal CDISC review and should soon be heading to a full public review. For those unaware, this first version of SENDIG-Genetox focuses …
Questioning my own SEND vocabulary
This week I’ve been thinking about some of the verbiage that we use to describe how we work with SEND. I’m worried that sometimes this may be misleading, misused or misunderstood. An obvious example that springs to my mind is the use of the word ‘dataset’. The correct use of this term in the context …
The headache of clinical signs
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 …
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 …
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