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serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyODM-68


If DataType=float, Length=N and SignificantDigits=S is a requirement that the receiving system be able to process and store all numeric values of magnitude less than 10N-S that are multiples of 10-S. Larger values may be rejected. Intermediate values may be rounded to the nearest multiple of 10-S
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the ItemDef element.
  • The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman readable name for the ItemDef.
  • The Name attribute must be unique within the set of ItemDef elements within a Study/MetadataVersion.
DataType(text | integer | decimal | float | double | date | time | datetime | string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float | partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime | incompleteDatetime | incompleteDate | incompleteTime | URI )RequiredSpecification of the allowable values and the intended use of the corresponding value elements.
  • A receiving system is expected to preserve the value and precision of the data. 
LengthpositiveIntegerOptionalSpecifies the number of characters allowed for the ItemData/Value when it is represented as a text. its length must be less or equal to N.
  • Systems that import ClinicalData must be able to process and store all text string with length  less than or
  • equal to N.
FractionDigitsDisplayFormatnonNegativeIntegertextOptionalSpecifies the number of digits to the right of the decimal point when the DataType is float.Display format supports data visualization of numeric float and date values. 
VariableSettextOptionalADaM variable set, e.g. Dose, Analysis Parameter, Treatment Timing.
CommentOIDoidrefOptionalReference to a CommentDef with sponsor provided information related to this ItemDef,
  • Must match the OID attribute of a CommentDef element within in this Study/MetaDataVersion.
  • The CommentOID attribute references a CommentDef element that may carry submission information as described in the SDTM (available at https://www.cdisc.org/standards/foundational/sdtm).