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 them when reviewing the submission.

However, as they would not be required, why would any organization actually do this?

I suppose the first thing that comes to mind is the fact that SEND costs money. It just does. I think we’ve all got accustomed to that idea. It also takes time. Time and money are two very persuasive arguments, yet there are organizations already getting on board with this new standard.

We have seen this before. Whenever the agency adds to the Data Standard Catalogue, they always add a support date that’s in advance of the requirement date. Typically, they issue verbiage along the lines of “…strongly encourage the use of…” to indicate their desire to receive the standardized data ahead of the requirement.  FDA cannot simply add the standard and require it immediately, so industry gets a period to implement the new standard.

Anyone who remembers their similar position for SEND 3.0 and SEND 3.1 will know that any implementation period comes and goes far too quickly. Two years can feel like a long time, but it will be over all too soon.

So ‘Supported but not Required’ is a siren. A great, noisy, clanging call to action, telling us that this requirement will drop onto our desks with all the grace and elegance of a sledgehammer.

Some of you are already underway with implementation. Many more are getting educated on the new standard, which is something I’d highly recommend if you haven’t begun this already. Being better informed about its scope, content and expectation sooner rather than later will enable you to identify the impact of this new requirement on your organization.

Some organizations have already thought about how many studies will be impacted and given that it’s a relatively smaller number than general toxicology, they have already set about identifying an outsourcing partner to handle the requirement on their behalf.

However, would any organization actually provide SEND datasets as part of a submission, where they are supported and even strongly encouraged, but not actually required?

Well, I believe that several organizations did exactly that for SEND 3.0 and 3.1. Granted, not a great number of organizations, but a significant group for sure. Once ready, these organizations did in fact see value in putting their capability, the capability of their CROs and solutions partners to the test, secure in the knowledge that they had a safety net of knowing that there would be no refusal to file. Knowing there are so many complexities and moving parts, there’s certainly an argument to be made for testing out a new standard during the limbo period of ‘Supported but not Required’.

As usual, please send your comments, thoughts, disagreements or questions to

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.