Additional Timing and Qualifier variables could be included to provide the necessary detail to adequately describe an observation.
A domain is defined as a collection of logically-related observations with a topic-specific commonality about the subjects in the trial.
The dataset structure for observations is a flat file representing a table with one or more rows and columns.
The presence of an asterisk (*) in the 'Controlled Terms or Format' column indicates that a discrete set of values (controlled terminology) is expected to be made available for this variable.
Additional fixed structure, non-extensible special-purpose domains are discussed in the Trial Design model.
Most observations collected during the study (other than those represented in special purpose domains) should be divided among three general observation classes: Interventions, Events, or Findings: In most cases, the identification of the general class appropriate to a specific collection of data by topicality is straightforward.
In cases when the topicality may not be as clear, the choice of class may be based more on the scientific intent of the protocol or analysis plan or the data structure.
It is not possible to map the data from EDC DBMS to SDTM standards until the clinical trial completes.