Well, March 2021 turned out to be a big month in the world of SEND. The FDA issued their 90-day notice for the enforcement of the Technical Rejection Criteria (TRC) for Study Data. This means that the FDA will begin rejecting studies that don’t meet the criteria effective September 15, 2021.

We also had a new Technical Conformance Guide (TCG) drop from FDA, and yes as this blogger speculated, immune response data in an optional custom domain for IS, was added to the Guide.

We saw the Federal Register Notice (FRN) and then the obligatory update to the Data Standards Catalogue to support and later require SENDIG-DART v1.1 which is the CDISC SEND standard for Development and Reproductive Toxicology. This coincides with a lot of FDA activity around their Fit For Use (FFU) pilot for that DART standard, including the selection of sponsors participating in the pilot and then the scramble to produce the datasets in record time.

That was all just in one month. Damn, do those FDA folks ever sleep?!

Not wanting to be left out of the party, CDISC published SENDIG 3.1.1. While limited to changes to PC and PP domains, publication of a new version of SEND is a very significant moment.

We also of course squeezed in the Society of Toxicology, ToxExpo. Even when virtual like it was again, for many of us it remains the largest and most influential industry event of the year.  Also, like many of you, I am very much looking forward to being back on-site next March in the San Diego sun!

How do you feel about so much happening in a single month?

Personally, I’m very proud and excited. I was part of both of the teams that authored the SENDIG-DART 1.1 and the SENDIG 3.1.1 standards. I’ve volunteered so many hours to developing these standards, I want to see them adopted and required as soon as possible, and applied to as wide a rage of studies as is feasible. But I know that’s not everyone’s opinion. I know there will be many who struggle to keep up with latest changes. Many who do not even know where to go to look to find out what’s changing (maybe that’s how you first stumbled upon my blog!).

I’m sure there are many that see all of these updates and announcements and feel that it’s too much, too soon. I’m sure there are many also still getting to grips with some of the challenges of SEND 3.1, and the idea of SENDIG 3.1.1 and SENDIG-DART probably fills them with dread.

I know there’s an opinion in some quarters that SEND is a burden, a necessary evil, an unwelcome expense. Those are valid opinions and I understand what leads people to those conclusions.

Yes, I understand that point of view, but I still see the benefits outweighing the cost. Most of industry is on board with SEND. Whether your solution includes new tools, partnering with a service provider, or a combination of the two, most of our industry is over the initial hurdle and now up and running. I’m continually reminded of the benefits that SEND brings both to industry and to FDA. As I look back at March, I’m really excited and encouraged to see the pace of SEND adoption is picking up.

How do you feel about it? marc.ellison@instem.com to let me know.

Till next time


Published by Marc Ellison

Self-confessed SEND nerd who loves geek-ing out about everything to do with SEND. Active CDISC volunteer and member of the CDISC SEND extended leadership team. Director of SEND solutions at Instem responsible for all our industry leading SEND products and services.