Home › Forums › Where do I file…. ? › eTMF system- Filing document in the correct Zone.

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    • March 25, 2020 at 12:53 pm #2936
      Janna GonzalezJanna 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

    • March 25, 2020 at 2:26 pm #2937
      Allison GrosikAllison 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

    • March 27, 2020 at 7:46 pm #2968
      Janna GonzalezJanna 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

    • March 30, 2020 at 5:26 pm #3013
      Allison GrosikAllison 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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