Are you ready for a tighter standard?

From my earliest introductions to SEND, one of the things that surprised me most was just how loose it was. It seemed that at every turn there were choices. The phrase “The sponsor chose…” occurs throughout the implementation guide when describing a particular representation of data. Several years ago, I was presenting at the Society of Toxicology meeting on this topic and I used the phrase “SEND feels like more of an artform than a standard”. I’d gone through the Implementation Guide and found over 50 instances where the guide implied some sort of choice as to how data could be represented.

When the SEND Implementation Guide was first written, it was intended to be flexible enough to accommodate the fact that data are collected differently in different labs and in different systems. Different organizations define and structure their glossaries and lexicons in different ways, and so the guide was written with adaptability in mind. There was a feeling that if the standard was too inflexible it would hamper adoption.

From what I have seen over the past few years, such flexibility has become its own hindrance. Adopters and implementers of the standard want clear and simple answers on how to represent data. The more subjective the reading of the Implementation Guide, the more time, effort and consideration need to be given.

It’s also worth remembering that the first versions of the Implementation Guide were written before anyone had ever thought of introducing CDISC conformance rules. The introduction of such rules highlighted the difficulty of having loose verbiage containing words such as “usually” or “typically”. I mean if a variable is “Usually expressed as the number” does that mean that it should break a rule if it was not numeric?

Today, as work continues on the content and updates for SEND 4.0, there’s a definite change in approach. The tone of the narrative sections is changing. Loose, flexible language is giving way to more specific, prescriptive language. While mainly driven by the need to have text that drives conformance rules, it feels like there’s also a general appetite to allow less variability between SEND providers. To make study representation more uniform, and to give implementors much clearer direction.

To me, this slight change in direction is a really positive move. I think this approach will be warmly welcomed when SEND 4.0 is published. Not only will it be much easier to define conformance rules, but it should also remove much of the subjective interpretation. Sponsors using multiple CROs and SEND providers should see a reduction in the variability in data representation. All of which seems a really positive step forward to me.

‘til next time

Marc