I love sharing my “Oh no” moments because we learn from our own mistakes and the mistakes of others (or we should).

“Adventures in Data Management” may seem a bit like an oxymoron if you aren’t in the industry. But believe it or not, each day can be an adventure, even a challenge. Hey, we even all but speak a different language for all its acronym-filled jargon and often misleading verbiage.

For example: a “Quality Event” is absolutely NOT an incredible party.

But whatever adventure or challenge DM has to offer, no matter what you do to take advantage of these opportunities, you are going to pull an “oops”. It’s inevitable, it’s universal.

I love sharing my “Oh no” moments because we learn from our own mistakes and the mistakes of others (or we should). Some lessons are hard, some are downright scary and some are more embarrassing than a face plant on the first day of your freshman year in high school (Me. That was me).

I was fresh out of new employee orientation (800 years ago) and SOP’s GCPs and study-specific trainings were whirling around in my head. I was feeling confident(ish). I could take on the world (ok, maybe a plastic globe representation-sized world, but I digress).

I managed to review listings with excitement and an eagle eye for any issues. And it was while navigating in and out of our EDC that I saw it. Nestled into a succinct response to a query sat the identifier of all identifiers, a patient’s name! It glowed like a flashing Vegas sign. My heart started to race. There was no
reason to fret! I knew exactly how to handle this (remember…the whirling SOP’s).

My first issue, and I was on it.

I quickly grabbed a screenshot of the identifier. Before you could say “Hey there lady, you wanna think about this for a hot second”, I created an email addressed to my study lead, assistant study lead and project manager as well as my line manager, attached the screenshot and sent it into the digital universe.

So, crisis averted, right? Ummm, no. And if you’re wondering what the problem is, I’ll tell you. When a patient identifier is used (made known), a silent alarm goes off at a secret location in DC, which triggers a land-air response from the CRF (Clinical Research Force). And, as the sound of helicopter blades whirred above my house (remote employee), I was hit with the realization of what I had
done.

Ok. That didn’t happen. While there are CRF’s in Clinical R&D, they don’t fly helicopters or descend on employee homes. Case Report Forms. That’s all they are.

Anywhoo, my “oops” wasn’t finding the identifier. It was taking a screenshot of it, then emailing it, creating additional electronic records of the identifier. That was most certainly not a reflection of or adherence to GCP’s. Corporate doesn’t like that, the regulatory agencies don’t like that, the client doesn’t like that, and well, the patient isn’t a fan either.

Thankfully this was quickly rectified. But not before I all but essentially alerted each lead/manager and my own manager that I had no idea what I was doing (not yet anyway).

While it was at the beginning of my career, I vividly remember that feeling: that panic. But, I can promise you that it never happened again. A painful and embarrassing lesson, yes. But one that taught me to pause and think.

What was your first “oops” and what did you do? Did you learn anything?