IRB Approval documents

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    • March 25, 2021 at 6:36 pm #4059
      Kadie Grammatico
      Participant

      I file my IRB approvals in 04.01.02, but do I need to make sure that all the approved documents are attached to the approval letter? OR is the approval letter enough to file in 04.01.02? Does anyone know if this is mandatory?

    • March 25, 2021 at 9:44 pm #4060
      Mariz Hanna
      Participant

      Hi Kadie, we file the approval letter in this section but in the eTMF we link all the approved documents thought supporting documents section exx. Protocol approval letter filed under section 04.01.02 and the approved protocol filed under section 02.01.02 and we link it to the approval letter

      Hope this helps

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