The symbiotic relationship between the SEND Implementation Guide and the FDA’s Technical Conformance Guide

In theory, the relationship between CDISC’s SEND Implementation Guide (IG) and the FDA’s study data Technical Conformance Guide (TCG) is pretty straight forward: CDISC defines the IG and then the TCG communicates “general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog” (section 1.1). The …

Can we make cheaper, faster SEND without compromising quality?

Recently, I asked one of our Senior Information Scientists, “If a customer asked you what they could do to make data easier to convert to SEND, what would you say?” Honestly, I was expecting maybe two or three bullet points of slightly vague suggestions. What I got was about three pages of very specific and …

What is the impact of the new FDA Technical Conformance Guide?

There’s been some significant news since my last blog post. Firstly, the FDA released a new version of the study data Technical Conformance Guide (TCG), and then we had the combined CDISC and FDA public webcast where some major changes to SEND 4.0 were announced. The biggest update to the TCG was the addition of …

It’s Sensible SEND Live! this week

I am not posting the usual written blog this week. Instead, we are having a ‘Sensible SEND Live!’ event on Thursday 13th April, at: If you would like to attend, but have not registered already, please use this link: https://register.gotowebinar.com/register/7321181066406386262 The event will be a live blog style presentation followed by a time for Q&A …

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 …