Hey everyone – I’ve asked Christy Kubin over at Charles River Laboratories to share some of her thoughts here on Sensible SEND. As well as being a long term CDISC volunteer and co-author of the SEND IG, Christy now leads the SEND Conformance Rules Team and like me, she is a bit of a SEND nerd. Enjoy her post and until next time, Marc

By Christy Kubin:

When Marc first asked me to put together some thoughts about SEND Conformance Rules, I’ll admit I was a bit intimidated. Marc’s love of SEND is contagious, and his blog talks about the best and worst parts of working with SEND in a way that is approachable and fun; which are not words most people associate with either “conformance” or “rules”.  While some people might assume that working with conformance rules is boring, it has quickly grown to be one of my favorite projects. Conformance Rules are impacted by all aspects of SENDIG development, and working from the conformance rules perspective has allowed me to better see how all aspects of the SEND standard work together. 

Like Marc, I truly love donating my time to CDISC to help develop the SEND standard.  The SEND Conformance Rules team was my first opportunity to lead a team, and I am lucky to work with such an amazing team (all of which are “SEND Nerds”).  SEND Conformance Rules are the translation of the SEND Implementation Guide text into logical statements documenting the characteristics a SEND dataset must have in order to be in conformance with the SEND standard. Writing SEND Conformance Rules is the ultimate opportunity to “nerd-out” on SEND as we pour through the SENDIG line by line and analyze every word. One of the most interesting things I found about writing conformance rules is the opportunity it gives the team to really dig into implementation guide text and challenge our preconceptions.  This has certainly led to many fascinating and passionate conversations!  In the end, SEND Conformance Rules must be about fact, and rules must be attributable to definitive statements in the SENDIG.  No conformance rules are written for assumed best practices or unwritten rules; there is no room in conformance rules for reading between the lines. Only definitive SENDIG statements can be translated into rules. 

When the CDISC requirement for conformance rules began, our team was tasked with writing rules for the published SENDIGs (SENDIG v3.0, SENDIG v3.1, and SENDIG-DART v1.1). As you might imagine, that proved to be an interesting challenge as those implementation guides were not written with the idea of rules in mind.  The team is taking what we have learned from those initial rule sets to suggest best practices for future SENDIGs that would ensure that future published implementation guides (such as the upcoming SENDIG-GeneTox) clearly and definitively state what is necessary for conformance to the SEND standard. This should result in cleaner, unambiguous versions of SENDIGs and conformance rules moving forward.

Thank you for allowing me to share my thoughts on SEND Conformance Rules with you.

Best regards,

Christy

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.