Trick or Treat Trial Master File

Trick or Treat TMF

Written by Nicole M. Palmer and John R. Nocero

Trick or Treat? What are you going to be for Halloween?

Today my team and I dressed as the Backstreet Boys as we presented a collaborative approach to compliance. It was something that we decided as a group to do – all in, no tricks.

The TMF is the same way – all in, no tricks. Have all documents up to date. You can find the documents when you need to, you hit on all the appropriate pieces. But the one other thing is why we do it.

We do it in case people have questions. When you look prepared, when you look the part and then you demonstrate it by coming back stronger and showing you do – people, especially inspectors will believe in you and your product. Everyone is always watching. The focus always should be – how can we do this better? How can we care more? That should always be a treat.

I don’t know about you, but I hate tricks. I’ve never liked them. There shouldn’t be any tricks when it comes to the Trial Master File. Here’s what I mean by this.

5 TMF Treats for YOU

1. All documents should be easy to locate. If I am looking for the Principal Investigator’s CV it shouldn’t be tricky to find. Just like at the grocery store, you should be able to see how they classify the candy aisle and the different types of candy.

2. Essential documents such as Medical Licenses should be current and up to date, just like Halloween candy. Would you hand out expired candy? No, because it would leave a bad taste in your mouth. Keep an eye out for any documents about to expire.

3. If you are using an eTMF system, it should be user-friendly. With a good eTMF system, you should be able to train someone on its basic functionality of it within one hour. No tricky electronic systems are necessary. If it takes you too long to get your Halloween costume on, you picked the wrong one!

4. Your TMF should be inspection ready at all times. If the FDA walks through the door you should be ready to have a conversation with ease. House is decorated. Check. The front porch light is on. Check. A bowl full of candy (not expired). Check. Everyone has a user-friendly costume. Check. You are prepared and ready to go! Come and inspect. Enter if you dare.

5.  You want to avoid any duplicate documents in the TMF. One way to achieve this is to do regular QC checks. If you are going to a Halloween party you want to make sure that you aren’t going to wear the same costume as someone else. Be prepared, communicate, and ask questions.

Working in the TMF doesn’t have to be tricky. You want it to be a treat. Something you enjoy. Something you look forward to. Something that you are proud of. Always remember your why. Be kind and accepting. Be nice. Be patient.

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