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If data are in scope for a domain defined in this guide, but not all data can be collected using the domain's collection fields, then fields may be added from the CDASH Model or created using guidance below. Prior to adding fields from the CDASH Model or considering a new field, confirm that none of the fields in the domain will fit the need. Fields may be added from the CDASH Model or created only when data are different in nature and are not in scope for existing domain fields.
If a logically related grouping of data is in scope for a domain defined in this guide, but not all data can be represented using the domain variables, then data may be represented by adding variables from the SDTM to the domain or by using a Supplemental Qualifier dataset related to the domain. Prior to adding variables from the SDTM or considering a Supplemental Qualifier dataset, confirm that none of the existing domain variables will fit the need. Variables may be added to a domain and Supplemental Qualifier datasets may only used when data are different in nature and are not in scope for existing domain variables.
Once confirmed, determine whether adding a
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field from the
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CDASH Model will fit the need. If adding a
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field from the
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CDASH Model meets the need, then a
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new field will not be
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created. New fields will only be
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created for
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when data are not in scope for a
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field defined in the
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CDASH Model.
The overall process for extending
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metadata is as follows
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:
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Place any non-SDTM variables in a Supplemental Qualifier dataset when variables cannot be selected from the SDTM.
Adding Fields from the CDASH Model
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)Gary - How can this section (meaning this whole page) be best addressed.
Creating New Fields
When considering creating 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:
- A field used for operational, Data Cleaning purposes only.
- A field used to collect data that have Direct Mapping to a target variable in the tabulation dataset.
- A field used to collect data that have No Direct Mapping to a target variable in the tabulation dataset.
Prior to adding a custom field to a CRF, confirm that none of the collection fields in this guide or in the CDASH Model fit the need.
Once confirmed, the following guidance will be used to add a new field to a CRF.The table below provides implementation guidance
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