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changes.mady.by.user Lorraine Sobson

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changes.mady.by.user Marcelina Hungria

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AttributeSchema Datatype or EnumerationUsageDefinitionBusiness RulesRule(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.