I started Sensible SEND thinking back to 2012 and my initial impressions & experiences of SEND. You can read that early post here, but as a fish-out-of-water I really struggled and was completely disoriented by this new world I’d landed in. I remember thinking to myself “These people speak a different language! What’s a Tee-Pee Tea Ref anyway?

However, thinking about it now, I had it easy. Back in 2012 there was only one SEND Implementation Guide and it was SEND 3.0. There were no FDA Business Rules, Validator Rules or CDISC Conformance Rules. Nobody talked about custom domains. I’m not sure there was even much discussion about nsdrg either. Back then, the define.xml was typically assumed to be some simple auto-generated table of contents. SEND was still several years away from becoming a submission requirement.

My biggest challenge was simply learning this new language. Just understanding why people kept talking about the differences between cats and rez-cats was as much as I could handle.

I know how long it took for me to feel that I was finally getting a handle on SEND, so I want to take a moment to spare a thought for those who are today’s SEND newbies.

They have all the same challenges of getting to grips with learning the IG and it’s disorienting variable names. However, they also have to get to grips with a regulatory landscape which seems far more complex now. We have multiple IGs, some of which inherit from a parent IG, like in the case of SENDIG-DART being the child of the main SEND 3.1 IG. We have different IGs with different requirement dates, and in the case of the main SEND IG, we have the same IG with different dates depending upon the FDA center receiving the submission.

Also, the situation regarding validator rules and tools is far more complex these days. Understanding the difference between FDA Business Rules, Validator Rules and CDISC Conformance Rules is challenging enough, but they keep changing and all the tools are soon to change as CDISC CORE rolls out for SEND. CORE is the CDISC Open Rules Engine, which is just one more on the ever-growing lists of acronyms that the SEND newbie needs to learn.

Fortunately, the quality of SEND training available today has significantly improved, and while available SEND experts are in limited supply, various organizations now offer consultancy and other services to assist in all aspects of managing SEND.

So, while SEND is more complex, there is more support available than ever before.

Thinking back to when I fell headfirst in to SEND, it was tough, but I wouldn’t have missed it for anything!

‘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.