Home Forums Where do I file…. ? IRB Amendment Protocol

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    • #3785
      Janna Gonzalez
      Participant

      1. Where to File a IRB Amendment Protocol Approval_v2.0?
      This document have two different approvals.
      consent
      Protocol v2

      Should I file this document in Zone 04.01.02 and 02.02.03?

      2. I have another IRB Amendment Protocol Approval v2.0. this document have three approval.
      Protocol v2,
      Consent,
      IRB Approval acknowledgment letter.

      Should I file in 04.01.02 and 02.02.03.
      Please Advise.
      Thank you,
      Janna

    • #3846
      Richard Golden
      Participant

      for both questions – are you asking about the approval documentation being distinct from the approved documents?

      if I understand you correctly, the IRB approval letter/form should go in 4.1.2

      while the actual approved documents go in their respective Zone 2 folders (2.1.4 for protocol amendment and 2.2.3 for ICF)
      it would be helpful to clarify exactly what you’ve received from the IRB

    • #3847
      Janna Gonzalez
      Participant

      This is a IRB Amendment and Approval Letter Acknowledges 3 separate items.

      This documents read for ‘3_Additional Approvals’.

      acknowledges 3 separate items (PV2, consent, and APR) I would like to know the suggested naming convention for documents approving of 3 separate items.

      Do I need to saved three of the same documents in the three different Zones?
      04.01.02,
      02.01.04,
      02.02.03
      Thanks,
      Janna
      thanksn

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