Home Forums Where do I file…. ? Artifact 08.01.03 Laboratory Results Documentation

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    • #2923
      Suellen Bigaj
      Participant

      From the CRO perspective, maintaining an eTMF, what would be expected to go into the below artifact?

      08 Central and Local Testing 08.01 Facility Documentation
      08.01.03 Laboratory Results Documentation
      Summary listings or individual subject reports provided by the central or local laboratory or other testing facility, e.g. results of biochemical testing, histological examination.

    • #4576
      Janna Gonzalez
      Participant

      EX. Document Type
      “Biochemical Testing
      Imaging Uploads
      Independent Rater Data
      Laboratory Results Documentation ”

      Janna

    • #4577
      Janna Gonzalez
      Participant
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