Essential Correspondence Definition

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      Kathleen Kane

      Does anyone have a good definition of essential correspondence for the TMF that they would be willing to share? I am updating SOPs, and would love to know how others define this to avoid extraneous correspondence in the TMF. Each study has a shared study inbox that we use for site correspondence, and by the end of a study has thousands of emails, many of which would not require filing in the TMF. I would like to define this in our SOPs to keep correspondence filed in the TMF narrowed down to the key study feedback where decisions and guidance to the site is provided, protocol clarifications, decisions on study subject participation, etc. Other items, such as review of study submission & documents, could be filed in our internal study files (e.g. shared inbox) and archived at the end of the trial and provided as needed during an inspection.

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