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Discussion on Recordkeeping Requirements for Recorded Phone Calls

  • 1.  Discussion on Recordkeeping Requirements for Recorded Phone Calls

    Posted 19-Apr-2018 15:16

    (j) Recordkeeping. The applicant must maintain for a period of 10 years records of all adverse drug experiences known to the applicant, including raw data and any correspondence relating to adverse drug experiences.

     

    Company A has an inhouse call center and received an external AE report. The call is recorded, a transcript generated and finally this is turned into an FDA electronic AE report.

     

    • What part, if not all , of this information is considered "raw" data per 314.80(j)?

     

    • What if Company B contracts call center and is not in possession of the recording but just a transcript. Is the raw data the recorded call, the transcript, both?

     

    Thanks

    Regina Ballinger



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