There’s a juggernaut on the horizon and it’s heading our way. Its ETA may be changing, but we need to prepare for impact. No, this isn’t the pitch for some low-budget 80’s action thriller, I’m talking about the next version of the SEND standard, and this one is a beast!
SEND 4.0 is the next update due for the SEND standard and many CDISC volunteers, including me, have been spending the last few months reviewing the Implementation Guide (IG). Firstly, I want to discuss the most significant news: The planned publishing date has moved from 2025 to 2026. That’s the publication date from CDISC, not the requirement date from FDA. The requirement would be expected in the following years. And, whilst we are still too far out to begin guessing when that may be, it’s still worth getting a little foresight on this upcoming standard.
So, why the delay? Well, it’s very much linked to that CDISC review that I mentioned earlier.
When reviewing version 4.0, the first observation that leaps out is the sheer volume of new content that has been added. For this reason, the review took the CDISC team far longer than expected and generated a significant number of comments to address. While not an exhaustive list by any means, here’s a quick rundown of the new studies and / or data types that will be added to SEND v4.0:
- Immune System Tests
- Cell phenotype
- Dermal
- Ocular
- Assessment of sexual maturity during microscopic examination
- Assessment of reproductive cycle during microscopic examination
- Microscopic targets staining assessment
- Pharmacokinetic input data for TK analysis
- F.O.B.s and CNS tests
Not only do we have entirely new sections widening the scope of SEND, but we also get significant improvements to the existing sections. Generally, across the whole IG, the wording is made clearer, instructions are simpler and more direct, and many of the examples have been greatly improved too. In the case of dosing data in the exposure domain, we are seeing a change in how data should be represented, with the domain being expanded to include the representation of missing doses, where these have been recorded as part of the data collection. Also, the emphasis of the domain is changing, and will now specifically state that the records in this domain should be the actual dose records collected.
It’s going to take some time to address all of the comments added to the IG and so the planned public review period and the final publication date have now been postponed by a year. This juggernaut may be further away than we first thought, but make no mistake, it’s going to create a bigger impact than we’d previously imagined.
As it approaches, I’ll keep you informed and prepared for its arrival.
’til next time
Marc
