Human beings have an inherent ability to see patterns in everyday objects, like recognizing shapes and faces in clouds. While that might seem ridiculous, pattern recognition is vital for us. Without it, we would not be able to do things as varied as being able to recognize faces; find the answers in a Word Search; or even appreciate music. However, this week no advanced pattern recognition skills were needed to see a common thread emerging.

My last blog post discussed the details of the FDA’s Technical Rejection Criteria (TRC). With little over one month to go (September 15, 2021) before the agency activates the TRC and begin rejecting submissions, it’s unsurprising that it’s proven to be my most popular post. Since it went live two weeks ago, there’s been a Federal Register Notice to confirm the September effective date for the TRC.

In addition, this week, we’ve seen CDISC launch the CORE project. This is a joint CDISC and Microsoft project to automate the application of the Conformance Rules. Launching with an hour and a half presentation, we were introduced to the vision and timeline for an exciting new technology that will automatically check for conformance to CDISC standards. CDISC started by creating standards including SEND, but then they added a written set of rules to ensure compliance to that standard. However, different tools may interpret that standard and even those rules in subtly, or possibly dramatically different ways. Regular readers of my blog will be well aware of my opinion on the difficulties caused by having a flexible, subjective standard that is open to interpretation. CORE sees CDISC take back ownership of the application of the rules to ensure that conformance is anything but subjective. Into this project, they are also adding the execution of non-CDISC rules, including the FDA Business Rules. CORE is something I’ll be watching and reporting back on in my blog as it takes shape.

This past week also saw CDISC publish SEND Conformance Rules v4.0 for evaluating the conformance of SENDIG-DART v1.1,  SENDIG v3.0, SENDIG v3.1, and SENDIG v3.1.1 datasets.

Throughout the week, I’ve been pouring over the FDA’s feedback on a few different studies, in order to assist some of our customers. When the FDA receive a SEND study, they will respond privately to the sponsor with feedback about their SEND datasets. This private feedback is one of the main methods employed by the FDA to continually improve the quality of SEND datasets being produced.

At first, these things: the TRC, CDISC CORE, new SEND Conformance Rules and the act of reviewing FDA feedback for several studies; may seem like a disparate set of unrelated topics, however standing back and reflecting at the end of the week, a clear pattern starts to emerge. Though independently, and seemingly co-incidentally, the quality of SEND datasets is being questioned and the bar is being raised. To that end, technology is being developed to ensure that we are all compliant, and that compliance is no longer a matter of opinion.

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.

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