AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
OIDoidRequiredUnique identifier.
  • Must be unique within a study.
Methodology(Digital | Electronic)OptionalDefines the type of electronic signature, including the meaning as required by 21 CFR Part 11.
  • If the signature is digital, it is based on cryptography. Otherwise the signature is electronic.
  • No labels