Summary

This article covers the inclusion/exclusion criteria dataset.    

Table of Contents

Mapping

Form Type IdQuestion IdInstructionValueColumn NumberColumn TitleData TypeData Format
ie,IE macroSTUDYID0STUDYIDString 
  constIE1DOMAINString 
  macroUSUBJID2USUBJIDString 
  nextSequenceIDSTUDYID,DOMAIN,USUBJID3IESEQInteger 
 inc01
$>&&value		rememberQstId
$>questionUniqueID		value
$>		4IESPIDString 
  constIN015IETESTCDString 
  constInclusion Criteria 1 Text6IETESTString 
  constINCLUSION7IECATString 
    8IESCATString 
  
$>
$>
$>
$>		if
$>then
$>else
$>fi
$>skipRowIf		ietestcd CONTAINS ‘IN01′
$>N
$>Y
$>
$>Y		9IEORRESString 
  if
$>then
$>fi		ietestcd CONTAINS ‘IN01′
$>N
$>		10IESTRESCString 
  visitNum 11VISITNUMInteger 
  visit 12VISITString 
    13VISITDYInteger 
 ietestcd
$>		invAnswerTime
$>toISO8601		 14IEDTCString 
 ietestcd
$>		invAnswerTime
$>studyDay		 15IEDYInteger

Summary of Questions

questionTypeIdQuestion TextData TypeAnswer Options / Default Value
ieynMet All Eligibility Criteria?Integer1||Yes::2||No
ietestcdCriterion Identifier:StringIN01||Inc 1::IN02||Inc 2::IN03||Inc 3::IN04||Inc 4::IN05||Inc 5::EX01||Exc 2::EX02||Exc 2::EX03||Exc 3::EX04||Exc 4::EX05||Exc 5
lbperfLab Status:Integer1||Done::2||Not Done

To download an example Excel File of this export click the attachment titled ie1 at the bottom of the page. 

Summary of IE

CRF data that captures inclusion and exclusion criteria exceptions per subject. All inclusion or exclusion criteria that are violated, should be stored here, even if a sponsor has granted a waiver or if the subject was admitted by mistake. In cases where a CRF may allow a response of ―Not Applicable‖ and this is checked, no criteria were violated, so these records would not be in IE.

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