Where to File Notification of Non-Approval and Waiver of IRB Requirements – Trial Master File Reference Model Discussion Forum

Tagged: IRB or IEC Approval IRB or IEC Conditional Approval IRB or IEC Decision IRB or IEC Rejection Conditional Approval Notification Notification of Non-Approval Waiver of IRB or IEC Requirements

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- March 5, 2021 at 8:37 pm #4017
  
  Janna Gonzalez
  Participant
  
  Hi All,
  
  Where to File Notification of Non-Approval and Waiver of IRB Requirements.
  
  These documents were removed from Zone 04- 04.01.02. IRB or IEC Decision
  
  IRB or IEC Approval
  IRB or IEC Conditional Approval
  IRB or IEC Decision
  IRB or IEC Rejection
  
  Removed from ver. 3.2.0
  Notification of Non-Approval
  Waiver of IRB or IEC Requirements
  
  thank you,
  Janna
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