Home Forums General Discussion Forum Essential Correspondence Definition

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    • #3682
      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.

    • #3688
      Jane Marie Johnson

      These definitions may be helpful however as you mentioned an SOP on Clinical Trial Communications is key. Include info on training to the definition, when and how to file in the TMF, how to use a central repository etc.

      Communications – Relevant
      Communications/correspondence that document agreements or significant discussion regarding trial administration, protocol deviations, trial conduct and adverse event reporting.

      Communications – Non-Relevant
      Ephemeral documents, defined as documents of trivial nature and therefore not business critical or only of short term value i.e. an email invitation to a meeting. These types of documents have little or no value as a record of compliance.

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