April 22, 2020 at 10:18 pm #3536Jane Marie JohnsonParticipant
Good afternoon! I am reviewing a US Device Sponsor’s process for ensuring proper archiving of site email correspondence and would appreciate comments/suggestions. Unfortunately the FDA has not issued a guidance document similar to EMAs content, management and archiving doc.
1) The Sponsor IT department has created a secure study-specific email address for saving emails (in original PST format) “indefinitely” on the internal server. Regulatory authorities can be granted remote read-only access during an inspection.
2) The Sponsor Clinical Research Department has an SOP requiring all “relevant” internal and external emails (i.e. from sites, CROs, vendors etc), are copied to the study-specific email address
3) All stakeholders (including Sites, CROs, Vendors etc.) are trained on the requirement to copy relevant emails to the study-specific email address
4)The Sponsor is the Administrator of a Part 11 and HIPAA compliant “shared platform” eTMF with separate sponsor and site-specific sections. Appropriate Security and Access controls are in place. An FDA auditor can be granted read-only privileges during an audit.
5) Investigative site email servers may not be able to maintain records for entirety of the retention period.
At the end of the study, is it acceptable to copy the emails from the Sponsor server to the site TMF? Or should the site server be used to copy all emails to the site TMF? The latter will result in “non-relevant” emails also being stored in the TMF.
Thanks in advance!
April 24, 2020 at 3:59 pm #3547Eldin RammellParticipant
Hi Jane Marie,
I’m not sure if the query is looking for how to ensure the long-term archiving/retention of emails for x years, or whether it is simply how emails should be filed/integrated into the TMF. Archiving means actions taken to ensure the long-term safety, security and integrity of records so not sure how this would necessarily be different for emails, other than maybe different file formats. Only reason I’m asking is that the question is posted in the “archiving” forum.
Having said that, just to let you know that there is a TMF Reference Model sub-team looking specifically at best practice for the management of electronic mail, including the long-term preservation of email records. Shouldn’t be too long before they have something available for us!
April 27, 2020 at 8:01 pm #3551Jane Marie JohnsonParticipant
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!
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