Being the first post of the year, I thought it would be good to consider what the year ahead looks like for the world of SEND.

The obvious place to start is looking at the standards that are going to become required by the FDA for submission. March will see SEND 3.1 become required for submissions to CBER. This follows the successful pilot and it’s great to see SEND being used by another FDA center. SEND 3.1.1 also becomes required for both CDER and CBER. While having two versions required at the same time may seem confusing, the agency clearly states in their Data Standards Catalogue that this means that the sponsor can select either of these versions as both are supported. The interesting point here, is that when SEND 3.1 follows the latest study data Technical Conformance Guide, it essentially represents the data as described in SEND 3.1.1, so the two are effectively the same. That said, the text and examples in version 3.1.1 for PC and PP data are far more useful and so I always advise people to consult SEND 3.1.1 when populating the PC and PP domains.

March also sees SENDIG-DART become a requirement for CDER. Limited to embryo fetal development studies, this has been a long time coming but it’s great to finally see it become a requirement. Also, let us not forget that Define-XML 2.1 becomes required from March.

As well as new requirements, this year we’ll also see some new standards being published by CDISC. We have SENDIG-GeneTox 1.0 for the representation of in vivo genetox data, and SENDIG-DART 1.2 which provides details and examples for representing juvenile tox studies. However, more than just expanding the scope to include juvenile studies, major sections of the guide relating to embryo fetal development were heavily rewritten to provide clarity on how data were expected to be represented. Additional examples were also provided for embryo fetal development studies and so those producing SENDIG-DART 1.1 for such studies would be well advised to consult version 1.2 for the improved examples and clarification.

Following on from the ‘Scope of SEND’ section recently added to the study data Technical Conformance Guide, we expect to see a continual increase in the demand for SEND as organizations are realizing that more and more of their studies are required to be in SEND.

Another trend that we’ve begun to see (that I think will expand further in 2023), is the desire to use the standardized data for warehousing, mining, sharing and various other uses that go beyond submission. Over the past year or two, I’ve seen the appetite grow for this type of usage and while this is currently a bit of a niche interest (as most organization are still just focusing on submission compliance) it’s an area that is gaining more interest and activity all the time.

However things end up playing out in the world of SEND, it certainly looks to be another interesting year ahead with continued expansion of scope, requirement and usage of the data.

‘til 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.