Why Define-XML files give me the Happy Mondays

During my formative years, there was a band from the north of England, not far from where I was growing up, called the Happy Mondays. Probably the most notable thing about them was one bandmember called ‘Bez’. His contribution was somewhere between cheerleading and performance art, as all he appeared to do was dance like …

Can SEND datasets be fully compliant…but still wrong?

In a recent post, we discussed how there’s quite a bit of emphasis at the moment on ensuring SEND datasets are compliant with the SEND Standard. Obviously, the main driver here is the activation of the FDA’s technical rejection criteria, which will result in the agency automatically rejecting applications which do not meet the required …

Did you see the recent paper from the JPMA SEND Taskforce Team?

Okay, first – some context… Without the FDA requiring SEND datasets, we would not have seen the industry-wide adoption and implementation of the standard. The change made by the industry, continues to fascinate me, in terms of both speed and scale. This drive for submission provides us with a well-defined standard, and one that is …

There’s a theme developing here

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; …

How to avoid rejection

It’s a basic human need: We want our work accepted and valued. Nobody wants to see their work rejected. It’s so obvious, it almost goes without saying. Worse still would be being rejected by a cold, heartless automated computerized system. That would be soul destroying. However, with the FDA’s latest deadline, automated rejections will start …

Is the world of SEND moving too fast?

Well, March 2021 turned out to be a big month in the world of SEND. The FDA issued their 90-day notice for the enforcement of the Technical Rejection Criteria (TRC) for Study Data. This means that the FDA will begin rejecting studies that don’t meet the criteria effective September 15, 2021. We also had a …