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Donna Dorozinsky

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