PRO Scripts and Site Activation Checklist – Trial Master File Reference Model Discussion Forum

Tagged: Patient Reported Outcomes, Site Activation

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- October 8, 2020 at 2:41 pm #3796
  
  Kathleen Kane
  Participant
  
  I have two questions regarding where to file a couple of documents:
  
  1. Patient Report Outcomes (PRO) scripts for PROs conducted over the phone. Should this be filed with other subject questionnaires in 02.02.02?
  
  2. The study team fills out a site activation checklist that the study team fills out to confirm that the sponsor/CRO has received all required essential documents prior to activating a site on a trial or shipping IP. Where should this be filed? Or is this type of documentation not typically filed in the TMF?
  
  Thank you!
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