February 3, 2020 at 3:28 pm #2821Debra WellsParticipant
Is there a general practice to QC emails before filing in the eTMF or file directly?
February 3, 2020 at 3:33 pm #2822Karen WilliamsParticipant
Hi Debra, I would advise you to QC emails before submitting to the eTMF. this way only study related clean emails will be in the eTMF and you/your team will not have to cleanup the communication section at the end of the study and you will be audit ready at all times. I hope this helps
February 3, 2020 at 3:59 pm #2825Sarah HoangParticipant
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.
February 3, 2020 at 6:07 pm #2826Debra WellsParticipant
Hope all is well – right now we are using a centralized mailbox, and then a study team member is sorting through and QCing before uploading to the eTMF. That means printing to .pdf.
Thanks for your reply.
February 3, 2020 at 6:20 pm #2827Donna DorozinskyParticipant
Hi Sarah and Deb, I would just like to add a couple of thoughts for you to consider.
1. The volume of emails in studies can be overwhelming. Emails should be uploaded to the TMF on a regular basis as complete communications. I recommend filing them at the lowest level of granularity. This makes finding them much easier. For example an email explaining a PIs affiliation with the investigator site could be filed with the PI CV. Then if a question comes up about the affiliation, the email explaining is right there. If this email were buried with a couple hundred other emails, no one would even know that it exists.
2. If an email has attachments that are filed elsewhere in the TMF, then I question if the email is even TMF content. If it does contribute to the story of the study, then go ahead and file the email without the attachment since it is already located elsewhere in the TMF. Hopefully the email references the attachment clearly and you can make the connection to the attachment when you are reviewing the communication.
3. Keep in mind if your practice is to file emails on a USB, that USB now becomes part of the TMF and should be managed as such.
Hope that this information is helpful.
Regards – Donna
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