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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.
Hi Debra,
I agree with Karen, I also suggest filing regulary (frequency to be determined) with complete e-mail chains to ensure TMF up to date and audit ready.
On the subject of e-mails, may I ask how e-mails are filed for an eTMF. Also how are attachments maintained? I understand for a paper TMF, e-mails may be printed and filed or saved on a USB, with this documented in the TMF plan.
It would be great to hear how e-mails are managed for an eTMF.
Kind regards,
Sarah