Standards for Tabulation

Standards for tabulation

Observations about study subjects are normally collected for all subjects in a series of domains. A domain is defined as a collection of logically related observations with a common topic. The logic of the relationship may pertain to the scientific subject matter of the data or to its role in the trial. Each domain is represented by a single dataset.

Each domain dataset is distinguished by a unique, 2-character code that should be used consistently throughout the submission. This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).

All datasets are structured as flat files with rows representing observations and columns representing variables. Each dataset is described by metadata definitions that provide information about the variables used in the dataset. The metadata are described in a data definition document (i.e., a Define-XML document) that is submitted with the data to regulatory authorities. The Define-XML standard (available at https://www.cdisc.org/standards/data-exchange/define-xml) specifies metadata attributes to describe SDTM data.

Data represented in SDTM datasets include data as originally collected or received, data from the protocol, assigned data, and derived data. The SDTM lists only the name, label, and type, with a set of brief CDISC guidelines that provide a general description for each variable.

The domain dataset models in Section 5, Models for Special-purpose Domains, and Section 6, Domain Models Based on the General Observation Classes, provide additional information about controlled terms or format, notes on proper usage, and examples. See also Section 1.4.1, How to Read a Domain Specification.

Be aware: 

• Data that were collected on separate CRF modules or pages may fit into an existing domain (e.g., as separate questionnaires into the QS domain, prior and concomitant medications in the CM domain).

What is data tabulation? ADD here

SDTM Section 1.4.1 

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.

SDTM - The SDTM Standard Domain Models

The collected data for a given study may use standard domains from this and other SDTM implementation guides as well as additional custom domains based on the 3 general observation classes.