Correspondence

[Sarah Wilmschen]

Hello, I have a general question regarding filing correspondence. Do you always file emails in the Artifact ‘Relevant communications’ of the corresponding zone? Or, depending on the content of the email, do you also file emails on other Artifacts than ‘Relevant communications’? Thanks in advance for your help!

[Jennifer Huddleston]

Hi everyone, when I was responsible TMF best practices within my organisation, I recommended that the Relevant Communications sections are considered last. Those a valuable sections, no doubt – but I wanted to avoid them becoming a dumping ground… Essentially, I asked everyone to consider where an Inspector would logically expect to see information to put the story together with the least amount of friction.

If the email was an approval for a block of extra visits to be performed outside what was specified in the Monitoring Plan, then I might file that email with the Monitoring Plans.

If the email is approval to suspend weekly status meetings and other activities described in the Scope of Work because a trial was delayed – perhaps that would be filed with the Scope of Work document.

If the email has been sent as a status update to replace a meeting, due to significant staff travel or conflicts, then I might file that email with the other meeting minutes for that meeting type.

If, after I have considered all other viable options, the email doesn’t seem to fit well in any non-Relevant Correspondence section, but it still feels like an auditable artifact then I file it in the most fitting one. However, I also asked my team to consider whether there is any other artifact better placed to capture the information. For example, if I have wads of emails providing comments on the protocol during a review cycle then I would prefer filing the collated review comments in a single document in the appropriate section – provided it still meets the necessary ALCOA requirements!

Basically, I tried to avoid using the Relevant Communications section so that what did end up there actually belonged!

[Michele Bastaldo]

In my experience we only file relevant communication in our study mailbox. See definition that we use below. All other correspondence that is not relevant the document owner is responsible for keeping up with those. At the end of the study if the study mailbox has irrelevant communication they are removed from the study mailbox. The study mailbox is set up in the same order as the TMF DIA Structure, thus correspondence is moved to the relevant folders. At the end of the study the study mailbox is archived (can’t update it). No correspondence needs to be copies it will remain within the study mailbox for that particular study.

Significant/Relevant email correspondence:
o Relevant correspondence that is necessary for key trial conduct activities and decisions should be retained.
o This includes correspondence with:
 Ethics committees
 Data safety monitoring committee
 Regulatory authorities (confirming sponsor approval of processes, documents and decisions and the communication regarding issues that arise in the trial conduct and how they are dealt with)
 Internal decisions, especially Medical Monitor and Safety related when study starts.
 QA related discussions
 Relevant correspondence other than (Letters – Meeting notes – Notes of telephone calls)
 Documentation of any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting
 Any other correspondence team members deem significant/relevant
 If in doubt copy the mailbox.

[Sarah Wilmschen]

Thank you very much for this helpful reply!

[Sarah Wilmschen]

…and here comes my second question relating to correspondence: In which format do you file the email in the eTMF (pdf, msg)? Is there a general recommendation? Thank you for your input!

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