You are correct that an important part of the question relates to the file format used for archiving emails as the eTMF will be used for long-term archiving as well.
During the study
1) All emails are stored on site, sponsor or CRO servers with full search functionality. The TMF plan does not currently reference this interim step but perhaps it should. (side note: must each server meet Part 11 requirements?)
2) In addition, “Relevant” emails are copied to a sponsor-controlled central email server also with full search functionality. Sites, sponsor team members and CROs are trained to copy the study-specific email address when sending relevant emails.(side note: must the central email server meet Part 11 requirements?)
After the study ends
1) The TMF plan states that only “relevant” emails will be maintained in the eTMF (it is Part 11 and HIPAA compliant). The process for transferring emails from a server to the eTMF results in the emails being converted to pdf format hence losing the ability to easily search by site, subject, date etc.
2) Within the Sponsor-controlled eTMF, each site has their own “secure” space where they could also store emails for archiving should they choose. This would result in duplication of “relevant” emails being stored in 2 locations within the eTMF. My understanding is that duplication is to be avoided however with limited search/sort capability perhaps in this instance it is practical.
I would very much like to hear comments suggestions regarding this process including whether storing/archiving emails long-term in original (.pst) format is preferred.
Thanks in advance!