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Analysis specifications in this guide provide a standard way to build analysis datasets. 

Domain specifications will be used with all guidance in this section and are organized with one specification per domain or dataset. All domain specifications begin with a description, expected name, and record structure for the resulting dataset. A domain specification table follows to describe dataset variables and their attributes. Assumptions for the domain are also provided to further guide implementation. Domain specification tables are structured to present one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.

The columns in a domain specification table are:




For TIG use cases, there are two streams that are not yet covered by the ADaM standard, however the individual health stream is very similar to the analyses done in drug development and the general ADaM structures will cover these types of datasets. however Product Health is not subject-based and therefore updates to the ADaM standard are needed to allow for identifiers in addition to the currently allowed USUBJID and SPEVID. For Population Health there is an analysis dataset section that addresses reference data which captures historic trends and results that are used as input for study analyses. there is a proposed stucture to cover these types of data.

ADaM specifications in this guide are instructions for implementing the ADaM to build analysis datasets for representation of collected or derived data. ADaM dataset specifications for the TIG are provided in:

  • Section x.x, Data Structures for Product Description
    • this section contains an ADaM example woth a class of ADAM OTHER that is not based on USUBJID like all other datasets in the current ADaM 
  • Section x.x, Data Structures for Individual Health
    • this section contains examples of ADSL, BDS, and OCCDS structures for some datasets to support typical safety analyses
  • Section x.x, Specifications for Population Health
    • this section contains the introduction of a REFERENCE data structure designed to capture historical results of various TIG components and several examples of historical data



Analysis Dataset Specifications list standard ADaM variables and define the required characteristics of standard variables (columns) that are frequently needed in ADaM datasets. The ADaM standard requires that these variable names be used when a variable that contains the content defined in the pre-defined ADaM variables sections is included in any ADaM dataset, regardless of dataset class. It also requires these ADaM standard variables be used for the purposes indicated, even if the content of an ADaM variable is a copy of the content of an SDTM dataset variable.

Currently ADaM has three structures: ADSL, BDS, and OCCDS, which correspond to the SUBJECT LEVEL ANALYSIS DATASET, BASIC DATA STRUCTURE, and OCCURRENCE DATA STRUCTURE classes of ADaM datasets. Analysis datasets that follow the ADaM fundamental principles and other ADaM conventions, but which do not follow one of the three defined structures (ADSL, BDS, OCCDS), are considered to be ADaM datasets with a class of ADAM OTHER. 



Currently the ADaM standards do not cover non-subject data. A reference dtata standard has been proposed to be used in the populaiton health examples section  and may be included in a future of the ADaM documents.

The columns in an ADaM dataset specification table are:

Row

1Variable NameSpecifies the name of the variable in the resulting dataset.
2Variable LabelSpecifies a descriptive label for the variable. 
3Type

Specifies the data type of the variable. Values for in this column are:

  • Num for numeric data
  • Char for character or alphanumeric data
4Controlled Terms, Codelist, or Format

Specifies applicable controlled terminology or formats with which to populate the variable. Values in this column are:

  • Names of one or more CDISC Controlled Terminology codelists with each codelist name in paratheses.
  • Short references to an external terminology (e.g., MedDRA)
  • The name of an external ISO 8601 format.
5Core

Specifies expectations for inclusion of the variable in the resulting dataset. Values in this column are:

  • Req for variables which are Required and must be included in the resulting dataset - however unlike SDTM a required variable may be null for any record. 
  • Cond for variables which must be included in the dataset in certain circumstances.
  • Perm for variables for which it is Permissible to include or exclude the variable from the resulting dataset. 
6CDISC Notes

Provides additional context for the intended use of the variable and may include:

  • A description of the purpose of the variable and/or what the variable means. 
  • Guidelines for variable use including rules for when or how the variable should be populated, or how the contents should be formatted.
  • Example values which could appear in the variable. Such values are intended to support understanding and are not intended to influence decisions regarding what values must be captured in the variable.


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