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March 30, 2020 at 5:26 pm #3013
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.
LMK Clinical Research Consulting