So here we are again in March, probably the most significant month in the SEND calendar. At Instem we are busy gearing up for the Society of Toxicology meeting, which will finally be in person again after a two-year hiatus, what with you-know-what. March also means that we are due to have the latest FDA’s Study Data Technical Conformance Guide land (TCG). What surprises will the latest version hold for us? Further clarification on the scope of SEND, perhaps? Possibly an update to the list of ‘desired’ Trial Summary study parameters? I guess we’ll have to wait and see.

Most importantly though for SEND is the significance of March 15th when it comes to the FDA’s Data Standards Catalogue. This is the date when the clock starts ticking on new requirements. If you are not fully up to speed with what I’m referring to, I won’t bore you with the technicalities, but suffice to say that March 2022 signals the 12-month countdown to some new FDA requirements for SEND.

Of these, the latest addition to the Data Standards Catalogue is SEND 3.1.1 which includes minor improvements to the PC and PP domains to bring them in line with the FDA’s TCG. Any organization who has been following TCG regarding these domains, should have no issues adopting this new version. As for the Implementation Guide itself, it now includes much improved examples for PC and PP to show how these domains function together and how they relate to EX.

One very curious thing to note with this addition to the Data Standards Catalogue is the fact that SEND 3.1.1 has been added, but without an ‘End Requirement Date’ for SEND 3.1. This means that come next March, organizations have the choice of which version of SEND they choose to use for their submission. This is quite different to the hard change over we saw between SEND 3.0 and 3.1. However, if we consider SEND 3.1 following the TCG as just being the same as 3.1.1, then there’s no real difference.

More significantly for some will be the start of the requirement for SENDIG-DART 1.1. This brings Embryo Fetal Development studies into scope for the SEND requirement. Following the successful recent FDA Fit-For-Use pilot, tools and organizations should all be ready to create and consume these new SEND packages.

Although far more specialized, SENDIG-AR also becomes a requirement for Animal Rules studies. These are clinical efficacy studies where animals are used as surrogates for humans because human clinical trails would not be possible.

Also, we are now 12 months away from SEND being required for CBER. There are no special SEND considerations specifically for CBER in the SEND Implementation Guide or TCG, the only real additional requirement for CBER regards immune response data. When these data are collected, they should be submitted in either a custom IS domain or as part of the LB domain.

Finally, the requirement that will impact us all is the move to Define-XML 2.1. There’s probably a broader topic for us to discuss at some point, to consider the wider implications of the value of the define fine.

So, it’s March and the clock is ticking. The next 12 months are going to see a flurry of activity as we all gear up for these new requirements to take effect in March 2023.

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.