Reply To: eTMF system- Filing document in the correct Zone.

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March 30, 2020 at 5:26 pm #3013
Allison Grosik
Participant

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