TMF Document Naming Convention

[Maria Lopez]

Hi, My name is Maria I’m the QM from a CRO. We are currently implementing the TMF RM in our organization.
We are now working on the documents naming convention and I’d like to know if anyone could give me some tips on how to name them or how others have named their documents.
Thanks in advance
Maria

[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.

[Maria Lopez]

Thanks so much for the very helpful information Kathie Clark.
Kind regards

[Shah Ashraf]

Hi Maria,

As Kathy brought up the most important part in naming the final document is to Identify the document without even opening it.

I am providing my sample of naming the documents that might help you out.

“Naming Convention (Trial Level)
(ProtocolNumber_DocumentType_Sub-artifacts short name/Document Description_Documnt date)”

“Naming Convention ( Country Level)
(ProtocolNumber_Country_DocumentType_Sub-artifacts short name/Document Description_Documnt date)”

Country:- 2 or 3 digit ISO code

“Naming Convention ( Site Level Level)
(ProtocolNumber_Country_Site Number_Last Name of PI_DocumentType_Sub-artifacts short name/Document Description_Documnt date)”

For documents related to CV’s and MLS we also capture the Name of the CV and MLS holder.

Sub-artifacts short name/Document Description :- Provides a short description about the document content. Becomes very important and makes it easy to identify a document by just looking at the Document name.

Hope this helps.

Best Regards

Shah Ashraf

[Michele Bastaldo]

Hello Maria,
My first step is to review the DIA Reference Model TMF Index. The last few columns gives naming convention examples. From their as stated name the document the exact name, version and document date that appears on the document. If the name is too long abbreviate where necessary.

I hope this helps!
Michele

[Janna Gonzalez]

Good morning,

Quick question? I have a Form Document# Type to file for my Study.

Should I use the Form#_Study#_Site#?

Ex. H00055_80-01_Gonzalez_10Mar2021

Should I use Study#_Site#_Form #

Ex. 80-01_H00055_Gonzalez_10Mar2021.

please advise.

thank you,
Janna

[Shah Ashraf]

Hi Janna,

I would use the 2nd option
“Study#_Site#_Form # Ex. 80-01_H00055_Gonzalez_10Mar2021.”

This will help you easily identify when you export or forward multiple documents.
All exported documents will be arranged by Study/Site .

Best Regards
Shah Ashraf

[Author]

Posts