Written by Nicole M. Palmer and John R. Nocero

Before you get started, it’s important to establish how you are going to name your files. This will ensure that your file names will remain consistent and that everyone will know what the process will look like and how it will work. Whether your TMF is paper, electronic, or in a hybrid format, file naming conventions are crucial when trying to be able to retrieve a document. Even if you have a repository for your documents that are not housed in the TMF it’s still important to have a process of how your documents will be named.

Perhaps you’ve heard this dialogue before?

Nicole- I don’t have time to access the TMF can you send me protocol V3?

Nicole- Does site XYZ have IRB approval for version 4 of the protocol?

Nicole- When was the last time site XYZ sent us their Site Signature Sheet (Delegation of Authority Log)?

These types of questions get asked often when you are the main person working in the Trial Master File. If someone has a question, they are coming to YOU for a couple of reasons. You are the one working in the trial master file all day and odds are, you are already logged into the eTMF system or if you are working in a paper TMF, you have access to the files and will be able to locate it faster than the person who is asking the question. In addition, you most likely have filed the document that they have questions about. Speed is of the essence when trying to retrieve a document.

4 Main Reasons Why the Name Game Is Important

1. When you need to retrieve a document quickly, there needs to be a quick search where you enter a few keywords to be able to locate the document.

2. The name should be able to tell you what the document is without even opening it.

3. You want to be consistent in your file name so that duplicates aren’t created.

4. Documents that have multiple versions such as IRB approvals need to be versioned controlled to access the document in a timely manner.

If you are using an eTMF system, the platform will most likely, depending on the system, provide an automatic name to the file. However, depending on the type of document, you will need to assign metadata to it to help others quickly identify the document. For example, trial, country, and site documents will need additional metadata to help you identify the document.

John, you love processes. Talk to us about how date formats matter in a file name.

I do love processes. Related to dates for me, they have to be consistent. I will accept 12-Jan-2023 or January 12, 2023, but not in the same document. We do have a process – MM-DD-YYYY. Savvy and I just made updates to it for that very reason. Consistency. That is what is important. That way we never get called out in audits  – internal or external. Everyone does it the same way every time.

Now, that is a cultural shift in mindset to get there. But we did. We must’ve answered why are we doing it this way, seemingly a hundred times. Guess what? We will do it a hundred more, It is important to us. Make time.

Consistency Nikki.

Having a process in place of how to name your documents and following it, is key to consistency. Inspectors want to see you have a process. They want to see you are following it. And that documents are easy to retrieve. Follow those 3 steps and you are setting yourself up for success in your file name.

As always, if you have a TMF question we would be happy to help you!

Nicole & John