Most Common Mistakes I See In the Trial Master File

TMF stands for trial master file that is the big file and the most important deliverable to hand over to the sponsor. These files are reviewed constantly to ensure that it includes all the necessary documents relevant to the clinical research study trials.

TMF reconciliation:

At some points during the study trials, all the study staff stops their work their work and gather at one point in order to have a look at everything included in trial master file. This is known as TMF reconciliation. During reconciliation, there are a lot of mistakes in the TMF.

Ø There are some most common mistakes in TMF as given below:-

1.   Naming:

This is the common and a simple mistake of naming incorrectly in the TMF that can be because of the wrong formatting as prescribed by the sponsors. These mistakes create difficult during TMF reconciliation when they have to correct everything written randomly without using specified format.

TMF has its own format for writing the names of sites, studies and locations.

2.   Signature and date:

CRAs cut off the signatures of the actual documents while scanning them into their computer while the dates remain at the same line. This is the most common mistakes made with the documents that are excluded by ordering a new and fresh copy of the documents from the site.

These signatures and dates are necessary to be mentioned in the documents especially to track the documents.

3.   Missing documents:

This is a huge mistake and carelessness that result in missing important documents that should be in the TMF. These missing documents can create a huge obstacle while reviewing the trial master files in order to review everything that happens within the study and during the study.

4.   Too many NTF’s:

Note to files is the document that is written in order to give the excuse for any missing document and errors and is mentioned in the TMF. Responsible person should find the missing document instead of giving excuses because there is no need for this note to files and excuses in TMF.

People add too many NTFs in the TMF at the end of the study to give excuses for their mistakes and errors.

These are some of the most common mistakes in TMF which should be avoided in order to satisfy the sponsor who is going to review the TMF at the end of the study.


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