Laboratory Validation Documentation – Trial Master File Reference Model Discussion Forum

Tagged: Central lab, lab validation doc, laboratory validation documentation

This topic has 1 reply, 2 voices, and was last updated 5 months, 4 weeks ago by Nick Hryciw ('her issue').

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- January 18, 2024 at 6:15 pm #5131
  
  angela falvey
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  Hi all – Specifically for a central lab, what are you all filing to 08.01.02 Central & Local Testing/Facility Documentation/Laboratory Validation Documentation? Thank you in advance.
- January 29, 2024 at 9:08 am #5135
  
  Nick Hryciw ('her issue')
  Participant
  
  Hi Angela,
  
  Our central lab vendor developed assays for testing of some of our samples. We have filed the validation testing and documentation in this section. Hope this helps.
  
  ~Nick
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