Summary

This article covers the medical history dataset. 

Table of Contents


Mapping

Form Type IdQuestion IdInstructionValueColumn NumberColumn TitleData TypeData Format
mh,MH macroSTUDYID0STUDYIDString 
  constMH1DOMAINString 
  macroUSUBJID2USUBJIDString 
  nextSequenceIDSTUDYID,DOMAIN,USUBJID3MHSEQInteger 
    4MHGRPIDString 
    5MHREFIDString 
  formUniqueID 6MHSPIDString 
 mhtermuppercase 7MHTERMString 
    8MHMODIFYString 
 mhterm
$>
codeTerm
$>uppercase
PT
$>
9MHDECODString 
 mhdiagqst 10MHCATString 
    11MHSCATString 
    12MHPRESPString 
    13MHOCCURString 
    14MHSTATString 
    15MHREASNDString 
 mhterm
$>
codeTerm
$>uppercase
SOC
$>
16MHBODSYSString 
 mhdiag
$>
invAnswerTime
$>toISO8601
 17MHDTCString 
 mhstdtctoPartialDate
$>toISO8601
 18MHSTDTCString 
 mhendattoISO8601 19MHENDTCString 
 mhterm
$>
invAnswerTime
$>studyDay
 20MHDYInteger 
 mhongo
$>
$>
$>mhendat
setVarQst
$>const
$>setVar
$>observationRelativeToReferencePeriod
ongoingQst
$>1
$>ongoingYes
$>
21MHENRFString 
    22MHENRTPTString 
    23MHENTPTString

Summary of Questions

questionTypeIdQuestion TextData TypeAnswer Options / Default Value
mhynHas the subject experienced any past and / or concomitant diseases or past surgeries?Integer1||Yes::2||No
mhspidMedical History Number:IntegersequenceNumber
mhcatType of Medical History being collected:StringGENERAL HISTORY||General History::SPECIFIC HISTORY||Specific History
mhtermReported Term:String 
mhongoOngoing?Integer1||Yes::2||No
mhctrlDisease controlled?Integer1||Yes::2||No
mhstdatOnset Date (dd-MMM-yyyy):PartialDate 
mhendatEnd Date (dd-MMM-yyyy):PartialDate

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

Summary of MH

The Medical History dataset generally includes the subject’s prior and concomitant conditions at the start of the trial. Examples of subject medical history information could include general medical history and gynecological history. Note that prior and concomitant medications should be submitted in an appropriate dataset from the Interventions class (e.g., CM).



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