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 …
Author Archives: Marc Ellison
Supported but not required by FDA – What’s the point?
SENDIG-DART v1.1 is currently supported by FDA, but not actually required, so should anyone really care? What’s the point of a standard that isn’t required yet? In this context, supported means that a sponsor could choose to include SEND datasets, and the FDA are willing and able to receive them and would expect to use …
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DART, SOT & an FRN – Just another week in the world of SEND
First, I noticed that I was getting a lot of email notifications and messages. More than usual. Something happened and the news was spreading. It was a Federal Register Notice (“FRN”) and it honestly came as a bit of a surprise. It was announcing that the FDA were adopting SENDIG-DART and stating they would start …
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A picture paints a thousand words
I know the title is the obvious cliché, but I had to do it. Sometimes things are obvious for a reason. I’ve just finished putting together my SOT/ToxExpo presentation and I’m still lamenting the fact that it’s virtual again this year. Anyway, as I alluded to in my previous blog post, this year’s presentation looks …
Beyond Compliance?
Beyond /bɪˈjɒnd/ Preposition “more extensive or extreme than; further-reaching than.” This week I have been writing the abstract for my talk at this year’s SOT meeting. Even though the event is again virtual, as you may have guessed by now, I’ll take any opportunity to inflict my opinions about SEND on anyone who’ll show up …
ADA & SEND: I’m conflicted
In the last CDISC SEND Core Team meeting, we got to discussing Anti-Drug Antibody (ADA) data, and its representation in SEND. We were debating what we’d recommend, and this is the cause of my conflict. The purist within me wants to scream “Custom Domain!”. The pragmatist knows the industry isn’t ready for this. I want …
SEND verses the Study Report
“SEND is just an electronic representation of your study report.” This used to be my stock phrase. I actually believed it. It was how the world seemed a few years ago. I meant every word of it. The concept is admirable, but the reality seems to be getting more removed all the time. The intention …
Out with 2020, SEND in 2021
Well Happy New Year one and all! After saying a final sayonara to 2020, I’m sure that you, like me and the rest of the world are hoping that 2021 ends up being so much better than its predecessor. That’s got me thinking about what’s happening with SEND in 2021. As discussed a couple of …
Should SEND dictate your choice of CRO?
This month marks the anniversary of the start of the requirement for SEND. It has been 3 years since SEND became required for INDs and 4 years since it’s requirement for NDAs. In our world, that really is not a long time. Yet, for many of us, SEND has completely changed our world. So, in …
The DART pilot is getting ready to fly: Part 2
In Part 1, I went into the detail of what the new SENDIG-DART standard covered; and now I’ll conclude by describing what’s involved in ensuring the industry is equipped with the necessary tools and services in order to successfully participate in the FDA’s Fit For Use (FFU) pilot for SENDIG-DART. The view from the trenches …
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