SEND: Why did they have to make it so damn hard?!

In my previous blog, I recalled the tale of my first experience with SEND. I’d assumed that standardizing nonclinical data would be straightforward, after all we have standard glossaries and lexicons from the likes of INHAND, and isn’t one 28-day study pretty much like another? Yet, this SEND thing seemed so alien and impenetrable to me at first. I suspect it is for a lot of other people too.

The suspicious amongst us may wonder if those creating the standards would intentionally make it as difficult as possible to keep themselves in a job for life. However, having now got on the inside of this CDISC thing, I can reassure us that this is not the case.

I think for most people, the first time they get a hint that this thing is going to be more complicated than they expected, is when they ask the deceptively simple question: “Does my study require SEND?”.  You’d be forgiven for expecting a straight Yes or No answer, but instead you’d be hit with a barrage of unexpected questions like “What is the study start date?”; “Where will it be placed in eCTD structure?”; “Which FDA center will it be submitted to?”; “What type of submission is it?”. While these questions may take us by surprise at first, the reason behind them is that not all study types are applicable for SEND, and the eCTD sections are used as a good indicator of what’s in scope and what’s out of scope. Similarly, not all centers within FDA have adopted SEND, and so the list goes on. The agency has tried to be as gentle as they can with industry, giving us time to implement SEND, and making sure that it’s only required where it is applicable.

Getting past that simple of question, is often like taking the Matrix’s Red Pill and as the film’s character, Morpheus, says “You take the red pill…you stay in Wonderland, and I show you how deep the rabbit hole goes” because what comes next is a whole new world of interconnecting standards, guidance, regulations, publications, terminology and the like. We suddenly realize that SEND isn’t a single standard, it’s multiple standards. For example, a single study may have data using the SEND standard, but also requires the Define-XML standard. It needs to apply Controlled Terminology (known as CT, and at the time of writing there are almost 40 different versions to choose from). The study also includes an nSDRG and should follow the FDA’s TCG and comply with their TRC and we suddenly find ourselves in a head-spinning world of acronyms (that’s Nonclinical Study Data Reviewers Guide; Technical Conformance Guide and Technical Rejection Criteria, just in case you were wondering).

Now drowning in multiple standards, you’d be forgiven for asking “Why didn’t they just write it all down in one place?” The answer to that is that each piece of this spinning jigsaw is written by a different organization or group. For example, CDISC writes the standard, but FDA requires the standard and PHUSE provides implementation guidance while NCI provides the CT (what? more acronyms!). It was important for FDA that they used an existing standard created, by industry themselves. So, we have multiple moving parts, each separately version controlled and each on different release cycles and timelines. For example, CT is published quarterly; FDA’s TCG is published twice annually while the main SEND IG is updated roughly every 5 years.

Then we come to the thing that makes SEND so damn hard, by far: Clinical Baggage. The fact is that that SEND is not really a nonclinical standard. It’s actually a clinical standard that has been butchered I mean amended, into supporting nonclinical studies. This brings with it many, many advantages, but it also makes SEND really difficult for the novice.  Subjects on human clinical trials visit their clinic and are examined, questioned and have results taken. Often, they don’t turn up exactly when they should, and this is all captured in the concept of a visit; which turns up in SEND because it was baked into the clinical standard up on which SEND was based. This is just one of many examples where we may feel like we’ve slipped into a surreal parallel world. (For the most surreal nonclinical example, check out page 215 of the SEND IG where it talks about noting why a result is NULL and actually gives the example “patient was asked but didn’t know”). Yes, I’m being a little flippant here, but these are extreme examples of an underlying truth that SEND is based on clinical and so has concepts that seem a little out of whack with nonclinical. In order to correctly render our nonclinical data, we need to understand this and know how to use these concepts in order to best represent our data.

Oh, and I didn’t even get time to explain why SEND has its own language and ask if you knew what an “Ex-Teepee Tea” might be.

Till next time


A SEND nerd

Hi and welcome, I’m Marc and I’m a SEND nerd. I’ve been a SEND nerd for 8 years, 3 months and 22 days. The last time I referred to the SEND Implementation Guide was 2 hours and 16 minutes ago. This is what my life has become. That is what SEND does to you, and I can’t get enough of it…

I suppose to introduce myself correctly I should tell you that I’ve been in the business of creating nonclinical software for over 23 years and for the past 8 years, 3 months and 22 days I’ve been a CDISC volunteer developing the standard and I’m currently leading the team that is developing the standards for Pharmacokinetic data.

I can vividly remember my first SEND meeting. It was at FDA’s White Oak facility and I was the new kid on the block. I’d been volunteered to volunteer by my boss as the discussions were now focusing on DART and I’d designed and written large parts of our Provantis ReproTox data collection system so, I knew my stuff … or so I thought. As the discussions started, I soon realized I was way out of my depth. These people were actually speaking another language. There was talk of “Oh Rez” and “Strez Sea”. I had no idea what was going on, and I had 3 days of this. These were smart people; these were good people; these were nice people; but why couldn’t they just speak English?

My contribution over those 3 days was minimal. I spent the whole time running to catch up, and in the space between meetings, I was busy quizzing people about what these strange words actually meant. But at some point during those eventful three days, something happened…

I found the debate enchanting, captivating and fascinating. Learning about these strange SEND concepts and passionately exchanging ideas about how to use them to best represent the nonclinical data, got to me and I was hooked. And I’ve been a SEND nerd ever since.

I caught sight of myself in the mirror the other day and the lyrics of Robert Palmer echoed through my mind “You might as well face it; you’re addicted to SEND”.

I’m such a SEND nerd, that I’ve even taken to blogging about SEND. I want to share my thoughts and experiences on the challenges of working with SEND today, as well as optimistically thinking about the wonderful possibilities it offers for tomorrow.

Where will SEND be in a few years’ time?

What new things will SEND allow us to do?

This will be a bi-weekly blog and, thinking back to that first meeting at the FDA, I will start by sharing my thoughts on the unspoken question of “SEND: Why did they have to make it so damn hard?!

Be sure to check out that post on October 21st.


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