Skeletons in the Closet Don’t Be the Next TMF Horror Story
It’s the time of year for scary stories. Usually these involve haunted houses, zombies, ghosts, and/or reanimated skeletons and are a welcome catharsis balancing the sugar high of pumpkin spice lattes and snickers bars. The most chilling stories, though, aren’t confined to the month of October.
We are, of course, talking about TMF horror stories. With decades of combined TMF experience, LMK’s TMF experts have seen it all, from the highs of TMF success to the lowest lows of TMF dysfunction. While every client, story, and TMF emergency is different, there’s one element common to the unhealthiest TMFs: skeletons in the closet. When we say skeletons in the closet, we really mean the unwelcomed facts of a failing TMF that we all wish weren’t true and might even forget about… until that dreaded day when the inspector knocks on the door.
The Zombie: Nobody is in Charge of Our TMF
Do you know who is in charge of your TMF? Do you know who to contact if you identify a systematic error? How would you communicate a study-specific change to your procedures? If you can’t answer these questions, your TMF might be a zombie, meaning it is lacking direction and TMF leadership.
At LMK, we advocate heavily for our clients to choose a TMF champion. The TMF champion takes ownership of the TMF. It’s important to have someone who has sole responsibility for the TMF for two main reasons. Firstly, because the complexity of the TMF warrants the full attention of an experienced professional. Clinical trial managers simply have too much on their plate to manage the TMF effectively. Secondly, because if no one is assigned a leader, it’s likely that no one will take ownership of the TMF, or worse, assume someone else has. Effective TMF leadership ensures TMF quality issues are addressed before they threaten the entire clinical trial. Poor TMF leadership, in contrast, is usually a main character in an increasingly ominous tale, where the TMF wanders aimlessly, mindlessly searching for its next unsuspecting victim.
The Ghost: We Don’t Know Where Our TMF Is
To fulfill its purpose, “to individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced,” the TMF must be a truly centralized repository acting as a single source of truth. But your TMF can easily become as ethereal as a ghost.
In the past, when TMF documents were largely paper, it was easy to end up with a fragmented TMF, where paper documents languished at the trial site or were locked away in the filing cabinet of an overworked administrator. The dawn of eTMF technology was supposed to fix this. With access to the eTMF from the cloud, the TMF could be everywhere at once, and the pain point of physical conveyance of the document to the archive was eliminated. But, as we’ve discovered, the ease of the eTMF can produce its own challenges. Without the right features and oversight, shadow repositories like email inboxes and desktop folders can easily become a second de facto TMF. When an inspector discovers the existence of these ‘shadow TMFs’, sponsor oversight will be called into question, and the process of identifying and cataloguing these ghosts will become a mandatory corrective action.
The Skeleton: We Haven’t Filed Much Since Start-Up
Are you really going to file that document later? Before long, your TMF will be looking a bit “bare bones.”
When paper TMFs were the norm, it was understood that paper documents took time to arrive in the TMF. A monitor might have had to physically fly to a site to retrieve documents, and signatures on a protocol, for example, might have only been collected when leadership congregated at an off-site investigator’s meeting. Today’s regulators have higher expectations. They know that your regulatory documents can be executed and filed in the eTMF instantly from anywhere with an internet connection. They know that your TMF has an audit trail and will use it to reconstruct the story of your TMF. If the inspectors see a large bolus of documents filed at start up and a second bolus in the week leading up to their inspection, they’ll see right through your last-minute plan, and it will result in an inspection finding.
The moral of this story is simple. Don’t become a character in your own TMF horror story. A healthy TMF begins with competent TMF leadership who support their TMF team and foster a culture of TMF accountability. Empowered and confident TMF professionals don’t let a small problem grow into a crisis. They champion their role, know who to ask for help, and understand the value of a healthy and contemporaneous TMF. They respond to TMF risks, fearlessly bringing the skeletons (or ghosts or zombies) out of the closet and into the light. They are truly the heroes of your TMF’s story. Working with them as part of a clinical operations team, you’ll find even the most frightening of TMF challenges can be solved with the right prospective and a commitment to incremental change.