myCSG © |Area: ADaM| Concept: C1011 : ADaM BDS - Criteria Flags | Lesson: L101a : Single parameter- aval based criteria-crit on all rows, flag on met records- single parameter |

Background for criteria flags
  • In clinical trial data analysis, we will often be interested in checking if the collected result meets a predetermined condition
  • We should be able to tell if the condition is met or not met 
  • One approach is to create a new variable and populate it with a value of Y when condition is met, and use a value of N when the condition is not met
  • We may also want to capture the condition that we are testing in a separate variable

ADaM implementation
  • CDISC ADaM standard allows for such type of analysis requirement and has standard variables for this purpose
  • We have CRITy and CRITyFL variables to capture the related information
  • CRITy variables have to be used to populate with a concise description of the condition being tested
  • CRITyFL variables have to be used to populate with Y when the condition is met, and with N when the condition is not met
VARIABLE_NAMEVARIABLE_LABELDERIVATION
CRIT1 Analysis Criterion 1 Set to 'Systolic Pressure > 160' on the records where PARAMCD="SYSBP"
CRIT1FL Criterion 1 Evaluation Result Flag For the records of PARAMCD="SYSBP": set to 'Y' on the records where AVAL > 160, else set to 'N' if AVAL is not null.
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