Page History

...

Standards in this guide are aligned with both use cases and activities. Given this, determining which standards to use may begin with selecting standards appropriate for both the use case and activity. The table below shows use cases and activities aligned with sections of this guide in which provide detailed instructions for implementation. It is recommended that all sections are read before the sections below  Sections referenced in this table are:

...

Standards for collection, tabulation, and analysis collect and represent data by common topics with standards for collection and tabulation grouping logically related data in domains and the design of analysis datasets customizable per analysis requirements. The scientific subject matter of the data further drives the selection of collection and tabulation standards, where the nature of the data must be within the scope of a domain for the domain to be used. Analysis needs drive the selection of analysis standards, where analysis requirements are supported by both the structure and the contents of the resulting dataset. Standards for data exchange are applicable to all use cases and support sharing of standard CRFs, tabulation datasets, and analysis datasets.

Determiining the standard to use

Observations and Variables - SDTMIG v3.4 - Wiki (cdisc.org) The SDTMIG for Human Clinical Trials is based on the SDTM’s general framework for organizing clinical trial information that is to be submitted to regulatory authorities. The SDTM is built around the concept of observations collected about subjects who participated in a clinical study. Each observation can be described by a series of variables, corresponding to a row in a dataset. 

...