February 18, 2021 at 5:51 pm #4007Jane Marie JohnsonParticipant
Jamie, Mark & Russell,
Thanks so much for all the effort put into both the email guidance document and the webinar training session. I am following up on a question we asked during the webinar about using “pointers” within the TMF to reference an external repository that maintains “relevant” email communications during the clinical trial and long-term after the trial has ended. We would very much appreciate your thoughts on the process we set up; i.e. where would you recommend changes:
1) ALL emails are retained on the Sponsor’s general email server in native format
2) In addition, study-specific central email addresses are created for each new study (ProtocolXXX@company.com)
3) All team members and Investigative Sites are trained on identifying “relevant” emails and the process for copying the central email address on such emails
4) Relevant emails received from 3rd parties (who are not trained to copy the central email address) are forwarded to the repository by the recipient
5) Obtained IT assurance that server/repository is secure, has restricted access to authorized users only, can produced human readable copies, emails are retained long-term in accordance with FDA requirements
6) All users are trained NOT to include any PHI in emails
7) All team members and Investigative Sites are trained to ensure subject lines accurately reflect email content. Emails are not sorted by TMF zone but rather all reside in a single repository.
a. If the TMF calls for a specific artifact that is communicated only via
email (i.e. monitoring visit follow-up letter) then that email is
pdf’d and copied to the placeholder in the TMF by the study manager.
8) Confirmed with IT that a “searchable”, certified copy of all emails within the study-specific folder can be downloaded and provided to an auditor
The recommendations provided in the guidance for filing/moving emails to each of the TMF zones contemporaneously or regularly during a trial are perhaps a gold standard but are not realistic for many small companies to implement. Any insight/suggestions you may have regarding our process would be much appreciated.
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