Page History

Gary - How can this section (meaning this whole page) be best addressed.

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. 

...

The overall process for extending metadata is as follows:

Adding Fields from the CDASH Model

1. Example 2: A study has subjects' blood samples sent to a central lab, which analyzes the samples and sends results to the sponsor via electronic data transfer. In a second study, the samples are analyzed locally and results are captured on a CRF. The laboratory results from both studies are stored in the SDTMIG Laboratory Test Results (LB) domain.

   
   

   
   

2. 
   

   
   

3. The Question Text and Prompt columns in the CDASH Model metadata provide different variations in the recommended text for asking the question on a CRF. For each question, the sponsor may elect to either use the Question Text or the Prompt on the CRF. Some text is presented using brackets [ ], parentheses ( ), and/or incorporating forward slashes. These different formats are used to indicate how the Question Text or Prompt may be modified by the sponsor.

   1. 
      

      Example: The CDASH variable --PERF, from the CDASH Model

...

1. 1. , has the following Question Text and Prompt.

      Question Text:  [Were any/Was the] [--TEST/ topic] [measurement(s)/test(s)/examination(s)/specimen(s)/sample(s)] [performed/collected]?

       Prompt:  [--TEST/Topic] [Measurement(s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)] [Performed/Collected]?

      The sponsor wants to add a question to a CRF that asks whether a lab specimen was collected, using a Yes/No response.

      The sponsor selects the CDASH variable --PERF and adds the appropriate domain code. LBPERF  

      Use either the Prompt or the Question Text on the CRF.

      Question Text: Was the laboratory specimen collected?

      • In the first set of brackets, the text option "Was the" is selected, as the study required only 1 lab test to be performed. [Were any/Was the] 
      • In the second set of brackets, the text used is "laboratory," which is the topic of interest. [--TEST/Topic (laboratory)]
      • In the third set of brackets, the text option "specimen," without the optional "s," is selected. [measurement(s)/test(s)/examination(s)/specimen(s)/sample(s)]
      • In the fourth set of brackets, the text option "collected" is selected. [performed/collected]

      Prompt: Laboratory Specimen Collected

      •  In the first set of brackets, the text used is the topic of interest (i.e., laboratory). [--TEST/Topic (Laboratory)] 
      • In the second set of brackets, the text option "specimen," without the optional "s," is selected. [Measurement(s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)]
      • In the third set of brackets, the text option "collected" is selected. [Performed/Collected]

...

Creating New Fields

When 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:

...