Analysis specifications dataset structures in this guide provide a standard way to build analysis datasets.
...
These structures are captured in the "CLASS OF DATASET" field in the ADaM metadata. Currently ADaM has 3 structures: the Subject-level Analysis Dataset (ADSL), the Basic Data Structure (BDS), and the Structure for Occurrence Data (OCCDS). Analysis datasets that follow the ADaM fundamental principles and other ADaM conventions but do not follow one of these 3 defined structures are considered to be ADaM datasets with a class of ADAM OTHER. Currently the ADaM standards do not cover non-subject data. A REFERENCE dataset structure has been developed for the TIG and will be considered for inclusion in future versions of ADaM.
For the TIG Product Description use case, ADaM fundamental principles will be followed with
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. Current ADaM principles and standards are implemented for the Product Impact on Individual Health use case. For the Product Impact on Population Health there is an analysis dataset section that use case, the REFERENCE dataset structure 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:
...
- 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
The following table describes ADaM dataset structures applicable to TIG use cases.
...
| Metadataspec |
|---|
| Use Case | Dataset Structure(s) | Implementation |
|---|
| Product description | ADAM OTHER | Follows ADaM fundamental principles but is not subject based | | Product impact on individual 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
| Follows ADaM fundamental principles and current ADaM structures | | Product impact on population health | REFERENCE | Follows ADaM fundamental principles and the new dataset structure developed for the TIG |
|
Analysis dataset specifications 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 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:
| Metadataspec |
|---|
| Row | Dataset Specification Column | Purpose of Column Content | | 1 | Variable Name | Specifies the name of the variable in the resulting dataset |
. | | 2 | Variable Label | Specifies a descriptive label for the variable |
. | | 3 | Type | Specifies the data type of the variable. Values for in this column are: - Num for numeric data
- Char for character or alphanumeric data
| | 4 | Controlled 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.- parentheses
- Short references to
|
an - external terminology (e.g., MedDRA)
- The name of an external ISO 8601 format
|
. | | 5 | Core | 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 - . 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
|
. | | 6 | CDISC 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.
|
|