Home Forums General Discussion Forum CRA training certificates of GCP and HSP in the TMF

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    • #4195
      Amrita Bains

      Does the CRA (CRO staff) training certificates of GCP and HSP need to be filed in the TMF? Thank you.

    • #4201
      Janna Gonzalez

      Hi Amrita,
      In my experience all key research personnel Qualification documentation are filed in TMF.

      Qualification documents for PI and all key research personnel
      • CITI Certifications (requirement is every 2 years)
      • Medical licenses for physicians and nurses
      • Current CVs for all study team members
      • Study-specific training: Documentation of protocol review with study team, in-service
      • Research-related training documentation
      • Spanning duration of study or assignment to study
      • Maybe maintained in a separate “credential binder(s)” with a documentation of where to locate this.

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