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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 or without the reason for not collecting the information, record(s)

can be created in the dataset to represent

these data.

In such cases, applicants may include:

• Individual records for each test not done for each subject or pool

• ; or
• One record for each subject or pool for a group of tests that were not done.

• 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"

• In such cases:
  
  • The paired values of --TESTCD and --TEST will represent a general description of testing in scope for the domain and will be used for all groupings of not done tests within the domain.  
    • --TESTCD will be the domain code concatenated with the word "ALL"; e.g., LBTESTCD = LBALL.
    • --TEST will be a 40 character or less descriptor for data in scope for the domain; e.g., LBTEST = Laboratory Data.
  • --CAT will represent the group of not done tests; e.g., LBCAT = URINALYSIS.
  • --ORRES will be null.
  • --STAT will be NOT DONE; e.g., LBSTAT = NOT DONE.
  • --REASND will be the reason the group of tests was not done when collected; e.g., LBREASND = 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.