The Top 4 Horror Clichés Lurking in Your TMF
With Halloween finally here, many of us are curling up on the couch with a bucket of candy and binge-watching horror movies. There are an abundance of these films to stream: cult classics, who-done-its, edge-of-your seat thrillers, gory slasher films, and the ever-popular zombie uprising. Some of them are truly terrifying, but many are better known for their frustrating, confusing, formulaic, or even laughably improbable clichés.
As ridiculous as these horror movie clichés may seem, many of them can also be found haunting the average TMF. Common but preventable TMF problems represent the overwhelming majority of inspection findings. An inspection finding, however, regardless of how ordinary, can still have chilling consequences for your team. So, grab another handful of candy corn and hold on tight as we unmask the top four horror clichés lurking in your TMF:
The Jump Scare
The scene has gone eerily quiet. The main character stands on the shores of a dimly lit cave before the surface of a glassy lake. His lips chapped, he bends down with a cupped hand to drink the water. The stillness is shattered as a corpse-like hand shoots up from the water with a loud splash.
We all have a sense of when the jump scare is coming, yet we all jump in our seats anyway. The same can be said about an inspection of a pivotal TMF. Despite numerous publicized inspection findings for a last-minute bolus of TMF documents just a few days before inspection, clinical teams continue to fail to meet basic contemporaneousness expectations. Every trial should be conducted as if an inspector is walking through the door. There is no reason to be startled.
The End… Or Is It?
A mysterious sentient blob has been terrorizing the town of Pleasantville and growing in mass as it consumes all living residents. An eccentric mad scientist discovers the ooze cannot tolerate the cold and vanquishes the evil goo with liquid nitrogen. Pleasantville celebrates his brave sacrifice before the credits roll and things are beginning to return to normal. Without warning, the scene cuts away to a small vial in his dusty lab; its stopper is being forced out and a familiar foe emerges from within.
Just because a clinical trial has ended does not mean the TMF is complete. Although historically thought of as a “library”, the TMF can no longer comply with existing regulations when treated as a static repository. For this reason, at LMK, we often discuss how TMF quality control is a cycle. TMF expectation and TMF reality must be continually compared to ensure that when a trial comes to an end, a TMF does not take months or years to close.
The Car Won’t Start
The zombies are approaching from all directions. The hero slides across the hood, behind the wheel of his Mad-Max inspired muscle car. Only one more step to a perfect getaway… starting the car. The key turns in the ignition and the familiar whine of an engine failing to start fills the theater. The zombies overwhelm the car and the hero fades out of view with a scream.
Failure to plan for your trial’s specific challenges can doom a TMF from the start. No matter how small or large the trial and no matter how advanced the TMF system used, there is no one-size-fits-all solution for TMF health. Even tools like the DIA TMF Reference Model are meant to be customized, and only after serious reflection and input by all stakeholders. A unified TMF plan, including a full QC cycle and schedule, fully mapped roles and processes, TMF health metrics, and customized tools like an expected document list, ensure your trial starts up right when it’s supposed to.
Why Call the Police?
The main character returns home to his front door ominously ajar. Inside he finds evidence of a struggle. He has been receiving menacing phone calls at three in the morning every night for the last week. He walks inside his home to investigate, calling out for his wife… who is nowhere to be found. From behind him, a dark figure with a dark hood nears.
Don’t feel obligated to take on your toughest TMF challenges alone. Sometimes the wisest decision is to take a moment to seek out expert TMF help. Poor TMF health is often the product of several interacting factors like antiquated processes, inflexible tools, or variable staffing challenges. LMK’s TMF experts have decades of combined TMF experience and represent an anthology of tested strategies primed to address the TMF challenges unique to your organization. There is no need to take on TMF challenges alone.
Contact LMK Clinical Research Consulting today for a complementary consultation and eliminate the horror from your TMF’s story.