Home Forums Where do I file…. ? Correspondence Reply To: Correspondence

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.