Filing Templates

[Lindsay Grier]

Hi Everyone!

Question – do any of you file templates in the eTMF? We file ICF templates absolutely, but I am wondering about documentation like source docs, logs, safety/pregnancy reports?

Thanks in advance!

[Yasmina Bourima]

Templates should not be filed in the TMF only Master Versions.

[Sarah Hoang]

From my understanding master versions of patient facing materials like the ICF and patient diary should be filed with the regulatory submission package in section 03.01/01 as per the DIA reference model.The master versions are then made site specific.

The DIA reference model also has section 02 central trial documents > 02.02 study documentation for subject diary, subject questionnaire, informed consent form, subject information sheet, subject participation sheet, subject participation card, advertisements for subject recruitment and other information given to subjects. Also there is section 02.01.07 for sample case report form (blank form/templates). 07.01.01 safety management plan also refers to templates.

From my understanding, auditors like to see patient facing materials provided to sites and that they have been provided in a timely manner e.g. following approval of a new amendment.

Also as per the model, there is 07.02.02 SAE report and 07.02.03 pregnancy reports.

It would be great to receive some clarify on what should be filed in the TMF.

[Eldin Rammell]

Absolutely Sarah. Master versions (templates) of study-specific central trial documents should be in the TMF. But not templates for visit reports, filenotes, etc.

[Yasmina Bourima]

The master version would also be the main document if several countries are involved, which one would file under Study Level. The country-specific translated ones under Country Level and the site-specific changes ones under Site Level. For me, a template is a version that still needs to be edited. Without specific content and only a given structure.

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