Written by Nicole M. Palmer and John R. Nocero
Some people love making a meal in the crockpot because when you cook low and slow the result is worth the wait. Then some people like to zap something quick in the microwave and have instant results. However, the results between the two do not taste the same right?
I don’t know about you, but I like to gather all the ingredients, make sure they aren’t expired, follow the recipe EXACTLY, and cook low and slow for a tasty meal. Anytime I’ve tried a shortcut or cooked something in the microwave, the result is less than par.
Having a TMF inspection ready can be a lot like cooking a meal in the crockpot. There are times when you think cooking in the microwave is a good idea, but in the long run, it can cost you time and money just like your TMF. This often occurs in study startups because there can be a lot of pressure to get sites activated quickly to enroll the first patient. However, this can lead to notes to files or deviations which are red flags for the FDA to ask more questions. The last thing you want is a 483 on your lunch break.
When you are working in the TMF (cooking a meal in the crockpot)
You are going to want to:
- Follow your company’s SOPs and study plans. This is the recipe.
- Review the documents for completeness and ensure they are not expired. This is your ingredients.
- If your document passes QC then you can move it to final filed. This is where you add your ingredients to the crockpot and turn it on to cook.
- Once all your documents have been final filed you can run a report, smile and know you are inspection ready. This is where your meal is complete and ready to taste test.
If I were to cook in the microwave it may look something like this.
- A document comes in, I upload it immediately to the TMF and will review it later when I have time. Quick and easy. At least it’s in the TMF. Immediate satisfaction knowing that the document is in the TMF but may cost more time in the long run because who knows if it is complete or if there is a duplicate document.
John, do you prefer cooking in the crockpot or the microwave?
Nikki, I am currently a skillet guy, probably because I am only eating a limited amount of foods (eggs get you ripped). I am all about picking the right tool for the job and in this case, both work, but you have to use them the right way. I don’t love food prep. I love cooking big batches of food to save me time. I am no chef. Food is fuel. I love a crockpot because I like being able to toss an entire meal in there and leave it for the day and eat it when I get home. Now, if I want to heat up some of that quick, I grab it, toss it in the microwave, and then I am good to go.
The crockpot cooking approach with the TMF is the slow burn – it is the painstaking time you prepare in setup, audit readiness, inspections, etc. It will take longer because it is supposed to because it is right. You can’t use the microwave to cook the TMF – it is too fast, unfortunately, it is what many places do. They want something done yesterday. Crockpot cooking for TMF docs; Microwave cooking to refresh your docs as needed.
Having the right tools to do the right job is important to have an inspection-ready TMF and a tasty meal. If you rush the process or take a shortcut it can cost you time and money in the long run. If you do it right the first time it will be worth the wait. I don’t know about you, but I hate spending money where I don’t need to. Lastly, we are all given the same number of hours in a day, it’s what you do with those hours to make them count.
Nicole & John
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