Happy Halloween, spooky clinical trial professionals! It’s that time of year when we celebrate things that go bump in the night, from ghosts and ghouls to… well, un-audited source documents.
You see, Halloween and clinical trial compliance have more in common than you might think. Both rely heavily on rules, expectations, and a healthy dose of fear. On Halloween, you’re terrified of a kid showing up at your door in a last-minute ghost costume—a bedsheet with two holes cut out—demanding a full-sized candy bar. In clinical trials, the fear is similar: a last-minute audit with “uh-oh” written all over it.
What’s truly spine-chilling in our industry?
- The Monster of Missing Data: You’ve closed out a study, the data is locked, and then you discover it. A horrifying, data-filled abyss where a crucial patient visit was supposed to be. It’s the kind of thing that makes you scream, “It’s alive! Oh, wait, it’s not. And now we have to chase a ghost for the next two months.”
- The Phantom Protocol Amendment: You’ve meticulously trained your site staff, everything is running smoothly, and suddenly, a new version of the protocol appears. But this one is different. It’s a “phantom amendment” that was approved last month, but nobody seemed to tell you. Now, all your data is out of alignment, and your compliance is in grave danger.
- The Unexplainable Signature: This is a classic horror story. You’re reviewing a document and see a signature that’s not from any staff member on record. Is it a ghost? Is it an unlisted study coordinator? You’ll have to investigate this mystery, knowing full well that an auditor is watching.
So, this Halloween, as you hand out candy and admire the creativity of your neighbors’ costumes, take a moment to be thankful for a few things: proper documentation, a well-defined Standard Operating Procedure, and the fact that most of your study data isn’t hiding in a haunted house because all of the horror stories listed here can be avoided using CRIO.
Stay compliant, and have a safe and spooky Halloween!