Greetings of the season everyone! As this will be my last post of the year, I thought it would be interesting to look back at a few of the topics featured in the blog during 2022. Back in January I was hoping to see the publication of the SEND standards for juvenile toxicology (SENDIG-DART 1.2) and genetic toxicology (SENDIG-GT 1.0) as well as the addition of SEND 3.1.1 to the FDA’s data standards catalogue. While SENDIG-DART 1.2 has been approved for publication, it will actually come out in early 2023, shortly followed by SENDIG-GT. However, SEND 3.1.1 did make the catalogue in time resulting in a flurry of activity preparing for the requirement in March 2023.
Throughout the year, I’ve often discussed the passion and enthusiasm that I, and many other ‘SEND nerds’, have for SEND. In the post “SEND: it’s not everyone’s cup of tea…” I also acknowledged that not all of my readers feel as strongly about this standard as some of us do.
In the post entitled, “SEND Conformance Rules are NOT Boring!”, guest blogger, Christy Kubin described how creating conformance rules allows her and her team to properly “nerd-out” on SEND. In the “Who Cares About Define Files Anyway?” post, another guest blogger, Charuta Bapat, shared her passion for the Define-XML standard.
As you’d expect, I’ve given updates and opinions on the development of SEND and provided feedback from various CDISC and FDA webcasts and conferences in my attempt to keep this community informed.
There certainly have been one or two slightly controversial posts along the way too. Most notably this year, I talked about the amount of effort required to standardize Clinical Signs and dared to ask the question if it was really worth it, in my post called “The Headache of Clinical Signs”. I occasionally receive some correspondence following my posts, but this post in particular provoked far more reaction than usual. A few months later, a softly spoken gentleman, in the most respectful manner, gently told me that he strongly disagreed with my post. It was great to then have a discussion about it.
Since starting this blog over 2 years ago, I’ve treated it more like an editorial. A vehicle of sorts for putting across my opinions and asking provocative questions. I love it when the blogs generate debate and discussion.
Late in the year in “Nervous System Tests and SEND: What’s going on?” we dug into another controversial topic when I raised the question of the missing NV domain for nervous system tests. Clearly, I was not alone, and the topic was timely as others have been asking similar questions and provoking similar discussions. Hopefully, early in 2023 there’ll be an update on that for us to discuss…
Other recurring themes that held significant value for me throughout the year were around the scope of SEND, and the quality of SEND, which was the focus of the very popular post of “How Good is Good Enough?”
So, we certainly have covered a lot of ground this year, and I look forward to 2023 when we’ll see even more developments in the world of SEND.
What has SEND meant to you during 2022? A challenge, an opportunity or a little of both? As always, I’d love to hear from you…
‘til next time
Marc
Sensible SEND Blog 