Recently, more and more, I’m being asked my opinion about the scope of SEND and if a certain study or even a certain endpoint should be provided in SEND. Clearly, I’m referring to data which do not have an obvious example in the SEND IG. However, the lack of example cannot be the defining criteria …
Tag Archives: SEND Standard
The relative speed of SEND development
As we approach the holiday season and the eventual end of another year, I’m again thinking of how fast this year has passed. Also remembering childhood times when Christmas seemed to take forever to arrive. Now it seems I barely catch my breath and another year flies by. So yes, time is most definitely relative. …
FDA provides more detail on the Scope of SEND
This past week was the CDISC SEND Virtual Face-to-Face meeting, and yes, I still snicker like a schoolboy at calling something a ‘virtual face-to-face’, but hopefully it’s the last one and by next Spring we can be face-to-face in person. Anyways, as is usual, the highlight of the week was the FDA public meeting. As …
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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 …
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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 …
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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 …
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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 …
A unique insight into SEND
This week I caught up with Debra Oetzman from our SEND Services team. As one of the authors of the SEND standard, an active CDISC and a PHUSE volunteer, many of you may have already interacted with her. At Instem, Debra performs verifications of datasets from suppliers right across the industry. We got talking about …
Is SEND really that exciting?!
It was one of the finest moments of my career, but it didn’t exactly get off to a great start. At the Safety Pharmacology Society, I was invited to speak at the DSI Data Blast (think Safety Pharmacology meets WrestleMania). I introduced myself and explained that I was going to be talking about the Standard …
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