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When an entire examination (e.g., Laboratory Test Results (LB)), a group of tests (e.g., hematology or urinalysis), or an individual test (e.g., glucose) is not done for a subject or pool, and this information is explicitly captured with the reason for not collecting the information, record(s) could be created in the dataset to represent this information. A sponsor has 2 options: (1) to submit individual records for each test not done for each subject or pool, or (2) to submit 1 record for each subject or pool for a group of tests that were not done.
For example, if urinalysis is not done, then:

• LBTESTCD = "LBALL"
• LBTEST = "Laboratory Data"
• LBCAT = "URINALYSIS"
• LBORRES should be null
• LBSTAT should be "NOT DONE"
• LBREASND, if collected, might be "no urine sample present"

The following is applicable to results that are not collected via QRS instruments. Please refer to QS domain assumptions for expected variable population. 

• --ORRES will be populated with the result of the measurement or finding as originally collected or received, using controlled terminology when applicable.  
  • When applicable, the unit associated the value of --ORRES will be populated in --ORRESU, using controlled terminology. 
• Values will be populated in --STRESC when --ORRES is populated. The value of --STRESC will be:
  • Derived by the conversion of numeric values in --ORRES to numeric values with standard units. Standard units will be represented in --STRESU using controlled terminology.
    • Numeric --ORRES values with characters attached (e.g., a greater than (>) or less than (<) sign) will be converted to standard units and the value of --STRESC will maintain the attached character (e.g., >10,000, <1). 
  • The assigned of the value of --ORRES. 
    • For nonclinical studies, in the Macroscopic and Microscopic Findings (MA/MI) domains, --ORRES may contain a finding with multiple concatenated modifiers. In this case, --STRESC would represent only the finding without the modifiers. 
• Numeric values represented in --STRESC will be assigned to --STRESN. If --STRESC is a character value, then, --STRESN will be null. 
  • Numeric values with attached characters (e.g., >10,000, <1) are considered to be character results and will not be populated in --STRESN.