Versions Compared

Old Version 5

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version 6

changes.mady.by.user Kathleen Mellars

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Expand
titleCDASH IE Metadata Specifications
Metadataspec
Order
CDASH Variable Name 
Question TextPromptCRF Completion InstructionsCDASH Variable Name SDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1
IEYN
Were all eligibility criteria met?Met CriteriaRecord 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.IEYNIEYNWere all eligibility criteria met?Met CriteriaRecord 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
IECAT
What was the category of the criterion?Criterion TypeRecord whether the criterion exception was Inclusion or Exclusion.IECATIECATWhat was the category of the criterion?Criterion TypeRecord whether the criterion exception was Inclusion or Exclusion.LAST ATTEMPTED USE WITH THIS MEDICATION
3
IETESTCD
What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion IdentifierIf the subject was not eligible, record the identifying code for each criterion that was an exception.IETESTCDIETESTCDWhat was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion IdentifierIf the subject was not eligible, record the identifying code for each criterion that was an exception.