There have been rumors of a proposed Nervous System domain (NV) for many years, yet still nothing has been published and it’s not listed in the content for SEND 4.0. So, just what is going on? At the recent joint FDA and CDISC SEND meeting, the full scope of SEND 4.0 was presented, and so …
Continue reading “Nervous System Tests and SEND: what’s going on?”
It was going to be called SEND 3.2 but now it’s going to be called SEND 4.0. Why the change and does it really matter? As you may have guessed, the change is due to the scope of the updates. The addition of several new domains and data types mean this is seen as a …
Continue reading “SEND 4.0 – Just how big is this change going to be?”
There’s an argument I occasionally hear that absolutely infuriates me. It’s usually some variation on the line, “The FDA doesn’t care about the quality of SEND, so why should I?” I know I’m paraphrasing, and probably stating this a little too bluntly, but it’s based on the fact that the FDA’s Technical Rejection Criteria (TRC) …
Last week was the Fall 2022 CDISC meeting. As usual, the highlight of the meeting was the public joint presentation between CDISC and FDA. With each event, cross study analysis has slowly become more of a focus. This time, there were multiple presentations referring to this topic and the opportunity to use SEND beyond just …
Continue reading “Virtual Control Groups and more – Update from the CDISC Fall meeting”
“If you want to go fast, go alone but if you want to go far then go together.” Proverb I don’t like moving slowly. I like to feel that things are moving quickly, and the end is in sight. I can become frustrated when things do not move quick enough. Yet, I continually see the …
I write this as I arrive at the European Teratology Society in Antwerp, Belgium to present a poster relating to the SENDIG-DART. This feels significant for a couple of reasons. Firstly, and personally, this is my first in-person conference or meeting since the COVID lockdown. To be travelling for business really feels like things are …
Continue reading “SENDIG-DART is more tricky than regular SEND”
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 …
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 …
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 …
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 …
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