Reply To: TMF Document Naming Convention

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Kathie Clark

Hi Maria,

It’s good to keep in mind that the goal of naming is to 1) allow a user to find a document quickly by keyword search 2) accurately identify the content of the document and 3) allow a user (including a health authority) to understand what is in a document without having to open it.

Hopefully it is possible for your eTMF to produce automatic names for your documents that include key elements of metadata. I once had someone tell me there were 14 different ways of naming protocols in their organization! Obviously that is not helpful. On the other hand, simply identifying the document as a protocol (or amendment) is probably sufficient in an eTMF as there are not a significant number of these in a given study.

However, there are other cases where document type, site, etc. are not sufficient. For example, when naming IRB submissions and approvals, the system probably does not have enough metadata to assign a unique name. Having a dozen “IRB Submissions” only distinguished by date does not help an inspector know which one to look at.

In this case, there should be a variable part to the title in addition to the standard part. Submitters should be given guidance on what information to include in the variable part to accurately identify the document.