eTMF system- Filing document in the correct Zone.

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    • #2936
      Janna Gonzalez
      Participant

      Good morning,

      Question?

      I have a site Activation Letter for one of my study site.

      What Zone # can I file this document.

      Document Type- Site Management-Sub-type-Site set-up- Name/classification?

      Is this the correct Zone and Artifact?

      Thank you, Janna

    • #2937
      Allison Grosik
      Participant

      Hi Janna,

      I commonly see Site Activation Letters filed in 05.02.17 IP Site Release Documentation.

      I hope this helps!

      Best regards,
      Allison

    • #2968
      Janna Gonzalez
      Participant

      Thank you Allison,

      1) Should I File the Site Activation checklist 05.02.17 IP Site Documentation.

      2) Certification of Clinical Study, not sure where to file, do you have any suggestion?

      Thank you,
      Janna

    • #3013
      Allison Grosik
      Participant

      Janna- I agree with filing the ‘Site Activation Checklist’ to 05.02.17 IP Site Documentation.

      In regards to your filing question on the ‘Certification of Clinical Study’, it sounds to me to be either an Ethics Committee or Regulatory Authority Approval.​ I recommend filing either to 04.01.02 IRB/IEC Approval or 03.01.02 Regulatory Authority Decision dependent on the approval body.

      Best regards,
      Allison Grosik
      LMK Clinical Research Consulting

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