Home › Forums › TMF Management, Content & Processing › Filing Templates
- This topic has 6 replies, 6 voices, and was last updated 4 months, 2 weeks ago by
denise teuber.
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February 11, 2020 at 4:09 pm #2850
Lindsay Grier
ParticipantHi 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!
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February 12, 2020 at 7:12 am #2851
Yasmina Bourima
ParticipantTemplates should not be filed in the TMF only Master Versions.
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February 12, 2020 at 9:56 am #2852
Sarah Hoang
ParticipantFrom 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.
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February 12, 2020 at 10:01 am #2853
Eldin Rammell
ParticipantAbsolutely Sarah. Master versions (templates) of study-specific central trial documents should be in the TMF. But not templates for visit reports, filenotes, etc.
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February 12, 2020 at 10:08 am #2854
Yasmina Bourima
ParticipantThe 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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August 6, 2024 at 11:44 pm #5179
Anke Fronius
ParticipantI am a bit late to this discussion, but I frequently find myself in a situation where I would like to file a master/template, but cannot find a corresponding artifact on trial level.
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September 30, 2024 at 2:39 pm #5215
denise teuber
ParticipantI have a question on filing approved IRB ICFs that are provided in .doc format. My previous experience was to only file .pdfs of a document to prevent from editing. Any industry standard here? TY
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