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 getting back to normal again.
Secondly, and more relevant for this blog, is the fact my poster, “Preparation for the regulatory requirement for SEND for developmental and reproductive toxicology studies” is being shown with just months to go before the requirement date of March 15th, 2023 kicks in.
It describes the SENDIG-DART in terms of the scope of studies covered, and how the electronic data are to be standardized for tabulation. Put simply, a very brief introduction for the uninitiated.
However, the main focus of it is to provide advice and feedback from the learnings from the FDA’s Fit-For-Use (FFU) pilot. Instem prepared the SEND datasets for one of the studies that took part in the pilot. The lessons we learnt through that process were invaluable in preparing us ahead of the expected demand for conversions. Though we had our Submit™ software ready well in advance and we trained our team in the new standard, there’s nothing like working with a real study to see just how ready we are. Real data always throws up unexpected complications and challenges.
As well as describing the learnings from Instem’s participation, I also describe the main takeaways from the FFU. My personal summary is simply: SENDIG-DART is more tricky than regular SEND. I would say that though SENDIG-DART is quite focused and specific, it certainly shouldn’t be underestimated. Some of the organizations taking part in the FFU hit a few pitfalls. When the CDISC team took a look at the FFU, it was obvious that the Implementation Guide wasn’t clear enough in certain areas. While I wouldn’t go as far as saying it was incorrect, or even misleading, re-reading it through, we could see where some of the guidance may have been a little too subtle. For SENDIG-DART v1.2, much of the text was addressed in order to make the meaning far clearer. The meaning hasn’t changed, but hopefully now it’s far less likely to be misinterpreted.
I’m sure I’ve mentioned this before, but version 1.2 is currently out for public review, and only has a week or two left, so anyone intending to review it who has not done so yet, would be well advised not to delay.
My personal opinion when it comes to the SENDIG-DART, is that any organizations with studies needing converting, unless they have a high volume of studies, I’d advise that they use a specialist SEND vendor as the complexity and cost of implementing SENDIG-DART simply wouldn’t be worth it for only a small number of studies per year. Those with a higher volume would be well advised to engage with a SEND specialist vendor with experience with SENDIG DART for specialist training and consultancy.
‘til next time
Marc
