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In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experiences by the subject. 

Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.Has the subject had any medical conditions or events?
MHYN Not Submitted
<NY codelist>
Sponsor-Defined CRF Completion Instructions
MHSPID
_________________
Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.
MHTERM
_________________
Record the start date of the medical event or condition using this format (DD-MON-YYYY).
MHSTDAT MHSTDTC
_ _ / _ _ _ / _ _ _ _
Record the medical condition or event as ongoing (Yes) if it has not ended at the time of data collection; the end date should be left blank.Is the medical condition or event ongoing?
MHONGO MHENRF/ MHENRTPT
<NY codelist>
Record the end date of the medical event or condition using this format (DD-MON-YYYY).
MHENDAT MHENDTC
_ _ / _ _ _ / _ _ _ _
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
MHYN1Has the subject had any medical conditions or events?Any Medical HistoryIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.TextN/A
(NY)Yes; No

radio
MHSPID3What is the medical condition or event identifier?MH NumberSponsor-Defined CRF Completion InstructionsTextMHSPID






MHTERM4What is the medical condition or event term?Medical History TermRecord all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria.TextMHTERM






MHSTDAT5What was the medical condition or event start date?Start DateRecord the start date of the medical event or condition using this format (DD-MON-YYYY).DateMHSTDTC



prompt

MHONGO6Is the medical condition or event ongoing?OngoingRecord the medical condition or event as ongoing (Yes) if it has not ended at the time of data collection; the end date should be left blank.TextMHENRF/  MHENRTPT
(NY)Yes; No

radio
MHENDAT7What was the medical condition or event end date?End DateRecord the end date of the medical event or condition using this format (DD-MON-YYYY).DateMHENDTC



prompt

This is an examples of SDTM dataset used to represent the medical history collected on the above CRF. 


Rows 1-3:The reported events were coded using a standard dictionary. MHDECOD and MHBODSYS display the preferred term and body system assigned through the coding process. MHENRTPT was populated based on the response to the "Ongoing" question on the General Medical History CRF. MHENTPT displays the reference date for MHENRTPT, that is, the date the information was collected. If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE". See Section 4.4.7, Use of Relative Timing Variables, for further guidance.

Row Captions Debug Message

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mh.xpt

mh.xpt

RowSTUDYIDDOMAINUSUBJIDMHSEQMHTERMMHDECODMHEVDTYPMHCATMHBODSYSMHSTDTCMHENDTCMHENRTPTMHENTPT
1ABC123MH1231011ASTHMAAsthma
GENERAL MEDICAL HISTORYRespiratory system disorders2003
ONGOING2004-09-18
2ABC123MH1231012FREQUENT HEADACHESHeadache
GENERAL MEDICAL HISTORYCentral and peripheral nervous system disorders2004-07
ONGOING2004-09-18
3ABC123MH1231013BROKEN LEGBone fracture
GENERAL MEDICAL HISTORYMusculoskeletal system disorders2005-07-152005-08-31E
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Dataset Wrapper Debug Message

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