Director, SEND Solutions
How long have you been volunteering at CDISC?
This year actually marks my 10-year anniversary at CDISC as I started volunteering late 2012, attending my first face-to-face meeting at FDA White Oak in the fall of that year.
What encouraged you to volunteer your time and expertise with CDISC?
At that time, focus had moved from General Toxicology to DART (Reproductive and Developmental Toxicology). I’d been heavily involved in the design and implementation of the DART functionality in Provantis (our LIMS system) and so I was asked to attend the three-day meeting at FDA with the SEND team to contribute my knowledge and experience. I guess you could say I was encouraged by my boss. I had no idea what I was stepping into, having had no prior exposure to CDISC standards. Looking back now, I find it almost comical how unprepared I was and had no idea just what I was getting into. To be fair to my boss, he’d assumed this was a temporary engagement and once I’d shared my experience with developing the LIMS, I’d no longer be needed. However, I found myself gripped by SEND and 10 years later, I’m still volunteering.
How did you begin working in clinical research?
Upon leaving college, I was looking for work as a computer programmer. I was offered several positions, but one in particular seemed the most interesting and technically challenging. That was 25 years ago, and the company was Fraser Williams Data Systems who developed the Artemis line of nonclinical data collection systems. Soon after that, the company was acquired by Instem and 25 years later I’m still here, though it’s been over 10 years since I last wrote any code.
What did you want to be when you grew up?
I first wanted to be a movie director, then an artist, and then a rock star.
We love that you express your passion for CDISC through your blog “Sensible SEND”. Tell us more about the name and what inspired you to take pen to paper?
Most people blog about food or travel or some other hobby. I blog about SEND. It wasn’t my idea; it was suggested to me and my first reaction was that it was a terrible idea. I didn’t really know what a blog was and assumed that I was being asked to publish educational material teaching SEND. However, it soon became clear that the blog wouldn’t be a ‘how-to’ SEND guide, but more of an editorial piece where I would get to voice my opinions about SEND, and very quickly I realized I had a lot of opinions that I wanted to share and that got me very enthusiastic about blogging.
It’s a vehicle for me to share my thoughts. It’s not intended to be deliberately controversial at all, but I know that not everyone will agree with everything I say, and that’s kind of the point. Writing the blog has become one of the very best parts of my job. I hope it comes across quite informal, just as if we were having a conversation over coffee. Also, I should mention that from time to time I have ‘guest contributors’ , who are my fellow CDISC volunteers who then share their thoughts on certain subjects. These are individuals who are just as passionate about SEND, if not more so, and it’s great for me to see their take on it. The name was chosen because I like alliteration and because ‘Sensible’ means practical and functional rather than decorative, and I wanted the blog to focus on themes around the practical application of SEND.
Please provide a tip that someone would find helpful in working with CDISC Standards.
CDISC standards can be quite overwhelming, at least initially. We have the SEND Implementation Guides and the underlying SDTM. There’s Define-XML, Conformance Rules as well as an ever-evolving Controlled Terminology and it’s a lot to try and get your arms around. That’s before we start to grapple with the idiosyncrasies of a particular study. So, my advice would be to make use of experts. Don’t try and do it all yourself but get assistance from those who’ve been doing this for years. When I started working with SEND, I was fortunate enough to be able to call on a good number of experts to help steer me in the right direction.