IRB Approval documents – Trial Master File Reference Model Discussion Forum

This topic has 1 reply, 2 voices, and was last updated 3 years, 6 months ago by Mariz Hanna.

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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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