Domain specifications in this guide are instructions for implementing the SDTM to build datasets for representation of collected, assigned, or derived data. Domain specifications for the TIG are provided in:
Guidance in this section describes how to read domain specifications provided in the sections listed above. Implementers should refer to these sections when reading this guidance.
Domain specifications will be used with guidance in this section and are organized with 1 specification per domain or dataset.All domain specifications begin with a description, expected name, and expectations for the 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 1
The CDISC SDTM can be implemented for tobacco product studies using the domain specifications in the following sections:
All specifications begin with a table to describe the domain's variables and their attributes. A domain specification table includes rows for all required and expected variables for a domain and for a set of permissible variables. There is one row for each variable with columns to describe expected attributes of the variable in resulting datasets. The columns order of variables in a domain specification table reflects the expected order of variables in the resulting dataset.
The columns present in each domain specification are described below with the column name and purpose:
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| Num | Domain Specification Column Name | Purpose of Column Content |
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| Specifies the name of the variable |
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| the resulting dataset | | 2 | Variable Label | Specifies a descriptive label for the variable |
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the data type of the variable. |
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Values for in this column are: |
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| Controlled Terms, Codelist, or Format |
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| Specifies applicable controlled terminology or formats |
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with which to populate the variable. |
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Values in this column are: - The value for variable DOMAIN from CDISC Controlled Terminology (e.g.,
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- VS)
- Names of 1 or more CDISC Controlled Terminology codelist, with each codelist name in parentheses
- Short references to an external terminology (e.g.,
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- MedDRA)
- The name of an external ISO 8601 format
| | 5 | Role | Specifies |
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A domain specification table includes rows for all required and expected variables for a domain and for a set of permissible variables. The permissible variables do not include all the variables that are allowed for the domain; they are a set of variables that the SDS Team considered likely to be included. The columns of the table are:
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- For variables that do not include a domain prefix, this name is taken directly from the SDTM.
- For variables with a "--" placeholder in the SDTM, the "--" is replaced by the 2-character domain code.
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- This may be the same as the label in the SDTM, or it may be customized for the domain.
- Sponsors should create an appropriate label if they include in a dataset an allowable variable not in the domain specification.
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- Controlled Terms
- As noted in the table note, an asterisk (*) indicates that the variable may be subject to controlled terminology.
- The controlled terminology might be of a type that would inherently be sponsor-defined.
- The controlled terminology might be of a type that could be standardized, but for which a codelist not yet been developed.
- The controlled terminology might be terminology specified in value-level metadata.
- The name of an external code system (e.g., MedDRA) will be listed in plain text.
- Codelist
- A hyperlinked codelist name in parentheses indicates that the variable is subject to the CDISC Controlled Terminology in the named codelist.
- Multiple hyperlinked codelist names indicate that the variable is subject to 1 or more of the named codelists from CDISC Controlled Terminology. If multiple codelists are in use for a single domain, value-level metadata would indicate where each codelist is applicable.
- A hyperlinked codelist name and an asterisk (*) indicate that the variable is subject to either the named codelist from the CDISC Controlled Terminology or to an external dictionary. The specific dictionary is identified in the metadata.
- Format: "ISO 8601 datetime or interval" or "ISO 8601 duration" in plain text indicates that the variable values should be formatted in conformance with that standard.
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in the resulting dataset including information conveyed by the variable in the context of a data record and how the variable can be used. Values in this column are: - Identifier for variables which identify the study, subject, domain, pool identifier, and sequence number of the record
- Topic for variables which specify the focus of the data record
- Grouping Qualifier for variables which are used to group together a collection of observations within the same domain
- Result Qualifier for variables which describe the specific results associated with the topic variable in a Findings dataset
- Synonym Qualifier for variables which specify an alternative name for a particular variable in an observation
- Record Qualifier for variables which define additional attributes of the observation record as a whole, rather than describing a particular variable within a record
- Variable Qualifier for variables which are used to further modify or describe a specific variable within an observation and are only meaningful in the context of the variable they qualify
- Rule for variables which express an algorithm or executable method to define start, end, and branching or looping conditions in the Trial Design Model datasets
- Timing for variables which describe the timing of the observation
| | 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
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- for when or how the variable should be populated, or how the contents should be formatted
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- Example values which could appear in the variable. Such
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- values are intended to support understanding and are not intended to influence decisions regarding data to collect and subsequently represent in the variable. For guidance on the selection of data to collect, please refer to the appropriate regulatory authority.
| | 7 | 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 and cannot be null for any record. Such variables are basic to the identification of a data record or are necessary to make the record meaningful.
- Exp for variables which are Expected to be included in the resulting dataset, even if all values are null. Such variables are considered necessary to make the data record useful in the context of the domain.
- Perm for variables for which it is Permissible to include or exclude from the resulting dataset. Permissible variables must be included in the resulting dataset when data appropriate for the variable have been collected or derived, even if all values are null.
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