Source Document Templates

This topic has 2 replies, 2 voices, and was last updated 7 months, 3 weeks ago by Ashley Perez.

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- June 14, 2023 at 10:29 pm #5053
  
  Mariz Hanna
  Participant
  
  Hi All,
  Do source document templates have to be filed in TMF, if yes which artifact it should be under?
  
  Thank you
  sincerely,
  Mariz Hanna
- September 13, 2023 at 11:18 pm #5097
  
  Ashley Perez
  Participant
  
  We have Sponsor-provided source documents that we file in 05.04.11 (Source Data artifact) if that is helpful to you!
  
  However, I have a similar question: Is it a requirement to file the source templates or just a recommendation? We are filing the Sponsor-provided source templates that have been provided to all sites, but a small handful of sites chose to create and use their own source templates. We are trying to determine if we need to collect their templates to file them in the eTMF, or if it is okay not to.
  - September 14, 2023 at 12:57 am #5098
    
    Ashley Perez
    Participant
    
    I found this FAQ that seems to answer my question, and may be useful to you as well, Mariz: https://tmfrefmodel.com/a-not-required-artifact-is-shown-as-core-why
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