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Subject: Public Review for Electronic Trial Master File (eTMF) Specification Version 1.0



  1. Table 1 and Tables 3,5 contradict one another: Table 1 says ‘Organization-specific term has no Term Source URL’, Tables 3,5 say it can have.
  2. Table 3. None of metadata types can be reserved. Is it correct (i.e. Domain-specific)?




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