Red Flags You Can’t Ignore: More TMF Lessons from Love Is Blind
In our last blog, we introduced Love Is Blind, a Netflix reality dating show and social experiment with a twist. On the show, prospective couples meet, date, and get engaged, all without seeing each other by way of dating pods. These dating pods consist of two soundproof rooms connected by a speaker and microphone in the front wall. Couples only meet face to face after an accepted proposal, and their weddings take place four weeks later. If they’ve made it all the way to the altar, they face the nerve-wracking possibility that their partner might not say “I do”.
What could possibly go wrong?
In this post we’ll consider the darker side of Love Is Blind; more specifically, the red flags of Season 2 that hinted a blossoming relationship was headed for trouble. A red flag is a common metaphor for an early warning sign of negative tendencies and behaviors that have the potential to cause problems in the future. These are the moments in the first few dates, whether in person or in the pods, that give you a funny feeling in your stomach. Sometimes red flags can be a bit nebulous and other times they can mean “run for your life”. The choice of how to respond to a red flag is up to you.
As we found in in our last blog, many of the principles of healthy relationships can be applied to both the pods and the TMF. Unfortunately for us all, several of Season 2’s worst red-flag moments are equally transferable. Of course, you can always choose to ignore the red flags too… but do so at your own risk. Eventually the pressure will build, the truth will get out, and the narrative will implode. It’s a painful way to go about a wedding or a TMF inspection.
Red Flag: They’re All About Appearances
Meet Shake. Shake is a Season 2 participant that asked several inappropriate questions in the first days of the dating pods. For example,
“I love buying clothes for girls. What’s your size?”
“Will I have trouble picking you up on my shoulders at a music festival?”
Shake willfully admits in the Season 2 reunion episode that he probably shouldn’t have gone on a dating show premised on the notion that love is blind. It is Shake’s narcissistic tendencies that leads Deepti, Shake’s now ex-fiancée, to leave him at the altar—a move much applauded by other participants and social media.
But can a TMF be all about appearances? Absolutely! Consider the note to file. A note to file, or NTF, is a memo filed in the TMF that provides additional information or detail to study. NTFs are generally written to try and make discrepancies, errors, and omissions ‘look better’ to an inspector. But do NTFs actually make the TMF better?
The answer is a resounding ‘no’. NTFs can’t truly replace a missing document, prevent an error, or clarify a TMF that is fundamentally flawed. A TMF is only healthy when it is accurate, complete, and contemporaneous from the very start of a clinical trial. That’s not to say that NTFs can’t be useful, but usually they only serve as a warning sign of trouble for anyone who comes looking. If an NTF embodies the basic elements of good clinical research documentation practices and highlights your due diligence and preventative actions in response to a problem, that’s a good thing overall—but even the best NTF is just a band-aid.
Red Flag: The Feeling Isn’t Mutual
The romantic atmosphere of the dating pods in Love Is Blind belie a strong subtext of competition. After all, every participant is looking for ‘the one’. Who’s to say that your special person won’t get proposed to by someone else first?
Because of the fierce competition for mates, a few participants ended up engaged to their second choice. Jarrett, for example, wanted to propose to Mallory right up until the moment she accepted a proposal from Sal. Jarrett, freshly heartbroken from the news of Mallory’s engagement proceeds to propose to Iyanna. Similarly, Shayne almost lost his chance with Natalie when he confused her with Shaina, who he had intimate conversations with, even though he had already asked Natalie to be his girlfriend.
The uneasiness of these early red-flag moments only grew as couples interacted with each other after the ‘dating’ phase of the experiment… and the second choice became increasingly aware of their consolation prize status. In total, four engagements were directly or indirectly jeopardized by the resulting distrust, insecurity, and paranoia from realizing their partner’s feeling weren’t quite as strong as theirs.
But what does unequal attraction look like in a relationship with a TMF? For starters, it implies you are putting much more effort into the TMF than the results and benefits you are receiving in return. If your only interaction with the TMF is endless filing through inefficient workflows, you are living this red-flag moment and understand what it means for a TMF to be passive.
A TMF is not meant to be a dusty filing cabinet where documents go to die. A modern eTMF, when used to its full potential, is a paradigm-changing proactive trial management tool that will return your investment of time and effort by a factor of ten. When the TMF becomes active, there is no searching for documents in your inbox, no version control confusion, and no time wasted manually tracking aspects of a clinical trial that could be generated with a click. Moving beyond the basics, a truly correct, complete, and contemporaneous eTMF, via AI-enhanced reporting functions, can give unprecedented insights into TMF trends, risks, and resource allocation. Simply put, your TMF should love you back with matching intensity. If the TMF is purely a burden, something is deeply wrong.
Red Flag: Making Other Plans
Shayne and Natalie, an unlikely couple from Season 2, initially had great chemistry in the pods. Many of the other couples readily agreed that Shayne and Natalie were the couple most likely to get married. Sadly, things took a less positive turn upon their return to the real world. Natalie is a consulting manager who takes her work seriously. In early conversations with Shayne, she mentions sound finances being important to her and having money saved up for the future. After their engagement, however, Shayne told Natalie he “doesn’t believe in 401ks”, doesn’t believe in saving for the future, and spends $2,000 a month on food. Naturally, some conflict resulted from these differences.
A marriage lasts a lot longer than the 38 days it takes to film Love is Blind. A marriage means decades of new adventures, unexpected challenges, big changes, and important choices. Planning for these fork-in-the-road moments is important. Failing to plan can lead to making the wrong choice or having no choices at all, eventually leading to potentially unresolvable conflict.
This is also true of the TMF. Careful forethought and planning are prerequisites for TMF health. Every clinical trial is different and will therefore have certain documents and events that don’t fit the mold. For this reason, the actual TMF plan document can’t be the same for every clinical trial. In the same manner, your filing index can’t be the same for each study, or worse, an exact copy of the TMF reference model. What works for one company or clinical trial might not be right for your company or clinical trial. To avoid systematic and widespread TMF quality issues, big TMF risks need to be identified and discussed in a way that engages all stakeholders. Only then can they be successfully mitigated before the documents flow in. Skipping the groundwork may make today a little easier, but it’s only at tomorrow’s expense.
Just like the fire alarm in a movie theater or the nerves in our fingertips that react to a hot stove, relationship red flags serve a critical purpose. They are an early warning that something is wrong and give us the chance to react before it’s too late. That is, only if we interpret them quickly and correctly.
When you see a TMF full of NTFs, make a spreadsheet of documents in the eTMF instead of running an automatic report, or find that every TMF at your organization has the exact same TMF plan, it’s your turn to yell out “fire” and head for the exit. You should react to these or any TMF red flags as strongly to your new date complaining about their ex or being rude to the waiter at the restaurant. You’ve spent years building your professional confidence and judgment. So use it! It’s a lot easier to solve big problems before your family and friends have shown up at the wedding venue (or before the inspector has shown up unannounced). If you don’t believe me, watch episode 10, Season 2 of Love Is Blind. You’ll understand soon enough.