myCSG © |Area: SDTM| Concept: IE : Inclusion/Exclusion Criteria Not Met | Lesson: L101 : Inclusion/Exclusion Criteria Not Met |

 

Background
  • In every clinical trial, each patient will be enrolled into the study only if they meet prespecified conditions mentioned in the study protocol
  • These 'prespecified conditions' are called 'Inclusion criteria' and 'Exclusion criteria'
  • Subject should meet all inclusion criteria to be eligible for enrollment
  • Subject should NOT meet any exclusion criteria 
  • SDTM standard has a standard domain for capturing these findings - "Inclusion/Exclusion Criteria Not Met (IE)"
  • Note that we only capture the information for the inclusion criteria not met and exclusion criteria met in IE dataset
  • IE dataset belongs to Findings class and has an expected record structure of 'One record per inclusion/exclusion criterion not met per subject'

What type of information is typically collected or presented?
  • Date of assessment
  • Short name of the test
  • Name of the test
  • Result
    • in original units
    • in standard units (converted to standard terminology of Y/N)

Other notes
  • In most studies, IE criteria will be evaluated only once at the time of screening
  • In some studies, IE criteria will be evaluated more than once, for example at screening visit for the first time and subsequently at the visit of randomization for the second time.
  • In the above cases, we will present both instances in IE - using VISITNUM/VISIT to differentiate between these two instances of IE criteria evaluation 

In this lesson,

We will see a basic example on how to create IE domain


ELIGCRIT : Eligibility Criteria
Question Response
Date of assessment
[IEDAT]
Inclusion Criteria 1
[ICRIT01]

Yes?
No
Inclusion Criteria 2
[ICRIT02]

Yes?
No
Exclusion Criteria 1
[ECRIT01]

Yes?
No



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_ELIGCRIT
_ STUDYID Study Identifier Char Set to 'statschoice'
_ DOMAIN Domain Abbreviation Char Set to 'IE'
_ USUBJID Unique Subject Identifier Char Concatenate eligcrit.PROJECT and eligcrit.SUBJECT with a hyphen in between.
_ IESEQ Sequence Number Num Sort the records by USUBJID, IECAT, IETESTCD, IEDTC, IESPID and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
seq
_ IESPID Sponsor-Defined Identifier Char Populate using eligcrit.RECORDPOSITION in three digit format padding with leading 0's where applicable.
_ IETESTCD Inclusion/Exclusion Criterion Short Name Char
testcds		 Create a record for each failed inclusion criteria (result=No) and each met exclusion criteria (result=Yes).
Populate as 'INCL01' when creating a record using eligcrit.ICRIT01.
Populate as 'INCL02' when creating a record using eligcrit.ICRIT02.
Populate as 'EXCL01' when creating a record using eligcrit.ECRIT01.
_ IETEST Inclusion/Exclusion Criterion Char Populate as 'Inclusion criteria 1' when SDTM.IE.IETESTCD=INCL01.
Populate as 'Inclusion criteria 2' when SDTM.IE.IETESTCD=INCL02.
Populate as 'Exclusion criteria 1' when SDTM.IE.IETESTCD=EXCL01.
_ IECAT Inclusion/Exclusion Category Char Populate as 'INCLUSION' for the records with SDTM.IE.IETESTCD begins with INCL, and populate as 'EXCLUSION' for the records with SDTM.IE.IETESTCD begins with EXCL.
_ IEORRES I/E Criterion Original Result Char Populate as 'N' when creating a record for INCLxx.
Populate as 'Y' when creating a record for EXCLxx.
_ IESTRESC I/E Criterion Result in Std Format Char Populate using SDTM.IE.IEORRES
_ VISITNUM Visit Number Num Populate using eligcrit.FOLDERSEQ
_ VISIT Visit Name Char Populate using eligcrit.FOLDERNAME
_ EPOCH Epoch Char Populate using SDTM.SE.EPOCH by comparing IEDTC with SESTDTC and SEENDTC of each element of the subject. Populate as 'TREATMENT' when the record falls on the boundary of SCREENING and TREATMENT elements. Populate as 'TREATMENT' when the record falls on the boundary of TREATMENT and FOLLOW-UP.

epoch
_ IEDTC Date/Time of Collection Char Populate using eligcrit.IEDAT in ISO 8601 format.
_ IEDY Study Day of Collection Num If the SDTM.IE.IEDTC is on or after reference start date then SDTM.IE.IEDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.IE.IEDTC-SDTM.DM.RFSTDTC.
studyday
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