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Variable Name

Variable Label

Type

Codelist/ Controlled Terms

Core

CDISC Notes

DTYPE

Derivation Type

Char

(DTYPE)

Cond

Analysis value derivation method. DTYPE is used to denote, and must be populated, when the value of AVAL or AVALC has been imputed or derived differently than the other analysis values within the parameter. DTYPE is required to be populated even if AVAL and AVALC are null on the derived record.

Three common situations when DTYPE should be populated:

·     A new row is added within a parameter with the analysis value populated based on other rows within the parameter.

·     A new row is added within a parameter with the analysis value populated based on a constant value or data from other subjects.

·     An analysis value (AVAL or AVALC) on an existing record is being replaced with a value based on a pre- specified algorithm.

DTYPE is used to denote analysis values that are "special cases" within a parameter. For each value of DTYPE, the precise derivation algorithm must be defined in analysis variable metadata, even for DTYPE values in the CDISC Controlled Terminology. The controlled terminology for DTYPE is extensible. ADD LINK See Section 4, Implementation Issues, Standard Solutions, and Examples for examples of the use of DTYPE. 

Some examples of DTYPE values:

  • LOCF = last observation carried forward
  • WOCF = worst observation carried forward
  • AVERAGE = average of values

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If analysis timepoints are defined by relative day or hour windows, then the variables in the table below may be used along with ADY or ARELTM to clarify how the record representing each analysis timepoint was chosen from among the possible candidates. The record chosen is indicated by the analyzed record flag ANLzzFL (see ADD LINK Table 3.3.8.1 Indicator Variables for BDS Datasets). Note that the variables in table below may not be applicable in all situations and are presented as an option.

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