CDASH Ryze Example.Subject Inclusion/Exclusion Criteria

Order	Question Text	Prompt	CRF Completion Instructions	CDASH Variable Name	SDTMIG Target Variable	SDTM Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value
1	Were all eligibility criteria met?	Met Criteria	Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.	IEYN	IEYN	Were all eligibility criteria met?	Met Criteria	Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.
2	What was the category of the criterion?	Criterion Type	Record whether the criterion exception was Inclusion or Exclusion.	IECAT	IECAT	What was the category of the criterion?	Criterion Type	Record whether the criterion exception was Inclusion or Exclusion.	LAST ATTEMPTED USE WITH THIS MEDICATION
3	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?	Exception Criterion Identifier	If the subject was not eligible, record the identifying code for each criterion that was an exception.	IETESTCD	IETESTCD	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?	Exception Criterion Identifier	If the subject was not eligible, record the identifying code for each criterion that was an exception.

Page tree