How taking your kids to school and the TMF are similar
You’ve gone through the steps. You know the rhythms. The familiar routines. Get everything in its rightful place. It’s imperative to start off on the right foot and to keep the process moving at the right pace. It’s not always exciting, but it’s crucially important to achieve the end result you desire. The Trial Master File (TMF) and taking your kids to school may seem like unrelated tasks, but the same attributes lend themselves to success in both areas.
- Organization: Careful attention to detail and an organized process that can be replicated are vital requirements to both the TMF and getting your kids through the morning routine and to school on time. In the case of the TMF, all of the documents and records related to a clinical trial must be organized and tracked in a systematic manner. Similarly, when taking your kids to school, you need to make sure that they have all of the necessary items (e.g. homework assignments, lunch, appropriate outfit) and that they are mentally prepared for a day of learning.
- Planning: Sure, you can wing it if you want to. But you probably know how that turns out. Alarm clocks that go off too late, homework assignments that should have been finished the night before. Did your child mention there was a bake sale today and he’s supposed to bring something? Looks like you’re stopping at the grocery store on the way to school. As the old saying goes: failing to plan is planning to fail. For the TMF, you’ll save yourself from headaches by planning ahead to ensure that all of the necessary documents and records are in place before the trial starts, and by carefully and accurately updating them as the trial progresses.
- Compliance: Like it or not, life comes with certain regulations and standards, and that goes for both the TMF and getting your kids to school. For the TMF, the trial must be conducted in compliance with applicable regulations, protocols, and ethical principles. Similarly, when taking your kids to school, you need to make sure they are dropped off in the right location and at the right time, wearing proper attire.
- Responsibilities: Getting to the end goal successfully won’t happen unless someone steps up to the plate and takes responsibility to get the job done. The TMF process can be challenging and detailed, and it must be followed to the letter. Similarly, young children aren’t likely going to start cooking their own eggs for breakfast while keeping an eye on the clock. They need someone to watch over them and make sure all the I’s are dotted and t’s are crossed to give them the best chance at a successful day.
Both the TMF and getting your kids to school on time involve organization, planning, compliance, and responsibilities. Some days you may be frustrated. Some days you may need to ask for help. But over time, a well-designed, carefully followed process is the best way to reach your destination.