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 …
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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 …
The pros and cons of having a flexible standard
I feel I need to make a confession. I need to admit that being a vendor of SEND software and services, drives a strong bias in how I believe the SEND standard should be defined and implemented. In the last couple of postings, we’ve been discussing how flexible, or ‘subjective’ the SEND standard is. You …
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SEND: Can a standard be subjective?
You don’t need me to tell you that SEND is the standard for representing nonclinical data, but what would you think if I told you that just by looking at the data, it’s quite easy tell which software and organization produced the SEND datasets? How ‘standardized’ does that sound? In my last post, I touched …
The SEND Traffic Jam
I hope you enjoyed my last blog post that discussed the differences in the analogue world versus the digital world, and how this gets us into a debate about whether SEND should represent the data we collect, or represent the data we report. Following on from that, this analogue-versus-digital discussion has got me feeling a …
Skeuo-what now?!
Does SEND include any skeuomorphs? Okay, strange word I know – stay with me….. Why does my phone make the sound of shutter when I take a photo? It doesn’t have a shutter, and even if it did, I wouldn’t be able to control its volume level. Yet, I hear that satisfying old school shutter …
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 …
Supported but not required by FDA – What’s the point?
SENDIG-DART v1.1 is currently supported by FDA, but not actually required, so should anyone really care? What’s the point of a standard that isn’t required yet? In this context, supported means that a sponsor could choose to include SEND datasets, and the FDA are willing and able to receive them and would expect to use …
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DART, SOT & an FRN – Just another week in the world of SEND
First, I noticed that I was getting a lot of email notifications and messages. More than usual. Something happened and the news was spreading. It was a Federal Register Notice (“FRN”) and it honestly came as a bit of a surprise. It was announcing that the FDA were adopting SENDIG-DART and stating they would start …
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