Page History

...

The overall process for extending a domain is as follows:

During the development of conformant CRFs the tabulation domain to which the collected data will be mapped must be determined. The choice of the domain will be based on  to use does not depend upon the mode of transmission, the methodology used to generate the data, the medium used to store the data, the person who recorded the data, or the subject described by the data. The SDTMIG domain to be used affects what CDASH variable names, question texts, prompts, controlled terminology, and so on, to use. CDASH suggests a format to be presented to those entering the data, but it does not dictate any data structure in which to store the collected data (often referred to as a data management operational database).

Creating New Fields

When considering a new data collection field, determine whether the data will be used for an operational use case, such as data cleaning, or are actual data to be represented in a tabulation dataset. In general, new data collection fields (not already defined in the CDASH Model) will fall in one of following categories:

...