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Thread: Emails from Study email account to eTMF

  1. #1
    Forum Member
    Join Date
    Jan 2012

    Emails from Study email account to eTMF

    Dear All,

    We are considering the use of Study-specific email accounts (we are using Outlook right now - no switch to Gmail in the near future). This being said, I am wondering if any forum members are utilizing any innovative methods to electronically "file" their email in thier eTMFs systems for long term retention.

    We advise the "slow and steady" method of piecemeal importing into our (Documentum based) system. More often than not, however, study teams resist this and are choosing to print out relevant emails and file them in what is left our our paper TMF. I would be very interested in hearing any other methods (if they exist) that 1. retain the emails and their critical metadata over and 2. enable the emails to be accessible (linked to the rest of the TMF) over time.

    Thank you for any input. I hope I may also offer valuable input some day soon...


  2. #2
    Hi Peggy,

    I guesss this may be way too late now, but I think the recommended electronic document format that best fits your requirements is PDF/A.

    The Adobe Acrobat XI Pro software application offers an integration into Outlook which allows for producing an archive format of e-mails, either individually or by folder, into a single pdf file for eTMF storage. This includes attachments from e-mails, allows for an archive type pdf file that is able to be sorted by the usual columns of most e-mail softer systems (subject, date, size etc.), so this could be an ideal solution to your needs. However the usual metadata stripping occurs as with printed e-mails, there is no behind-the-scenes header data included.

    Given the adaptability of Outlook, it is entirely possible to include a plug-in/design a plug-in that will automatically include routing data from e-mails into a printed version of the e-mail - whether that's physical printing or through pdf software as a file - and can even collect this data from looking at the Internet Headers, copying the data and appending it to the start of an e-mail.

    Hope this helps,


  3. #3
    I agree absolutely with Justin. I think there is probably a difference of opinion within the agencies on this topic though. The draft reflection paper on trial master files from the EMA talks about retaining emails in PST format rather than PDF. However, this is definitely NOT a format that is suitable for long-term retention and in any case is a file format that is proprietary to Microsoft (so not applicable for GMail, Lotus Notes etc). Whilst saving to PDF or PDF/A does indeed remove some of the email header metadata, this metadata was also stripped from emails in the "olden days" when we printed down our emails and nobody ever complained about that! Given the choice between a file format that almost guarantees long-term digital preservation but loses a little metadata (arguably not particularly important metadata anyway) and a file format that retains everything but is difficult to manage, difficult to search, requires an email client to view and is difficult to retain in the long-term (25 years plus), I know which format I'd choose! The regulators keep urging us to take a risk-based approach and the new EU Regulation includes maintenance of the trial master file in that approach. I'd therefore recommend PDF or DF/A using such a risk-based approach.

    Incidentally, there are commercial add-in products that export the metadata in the PDF file but these have to be purchased separately and integrated into the email enterprise solution. Is it essential? I suggest not.

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