SDTM Example.Medical History

THE REFERENCES FOR

More information can be found in

SDTMIG Section 4.4.7, Relative Timing Variables needs to be linked to a Section in this TIG. This section seems to be missing.

In this example, a General Medical History CRF collected verbatim descriptions of any medical conditions or events experienced 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	Yes No <NY codelist>
Sponsor-Defined CRF Completion Instructions	What is the medical condition or event identifier? 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.	What is the medical condition or event term? MHTERM	_________________
Record the start date of the medical event or condition using this format (DD-MON-YYYY).	Start Date 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	Yes No <NY codelist>
Record the end date of the medical event or condition using this format (DD-MON-YYYY).	End Date MHENDAT MHENDTC	_ _ / _ _ _ / _ _ _ _

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	Controlled Terminology Code List Name	Permissible Values	Query Display	List Style
MHYN	1	Has the subject had any medical conditions or events?	Any Medical History	Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.	Text	N/A	(NY)	Yes; No		radio
MHSPID	3	What is the medical condition or event identifier?	MH Number	Sponsor-Defined CRF Completion Instructions	Text	MHSPID
MHTERM	4	What is the medical condition or event term?	Medical History Term	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.	Text	MHTERM
MHSTDAT	5	What was the medical condition or event start date?	Start Date	Record the start date of the medical event or condition using this format (DD-MON-YYYY).	Date	MHSTDTC			prompt
MHONGO	6	Is the medical condition or event ongoing?	Ongoing	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.	Text	MHENRF/ MHENRTPT	(NY)	Yes; No		radio
MHENDAT	7	What was the medical condition or event end date?	End Date	Record the end date of the medical event or condition using this format (DD-MON-YYYY).	Date	MHENDTC			prompt

This is an example of an SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the sponsor to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset used MHENRTPT. More information can be found in SDTMIG Section 4.4.7, Relative Timing Variables.

Rows 1-2:

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".

Row 3:

The start and end date of the reported event was displayed.

mh.xpt

Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHTERM	MHDECOD	MHCAT	MHBODSYS	MHSTDTC	MHENDTC	MHENRTPT	MHENTPT
1	ABC123	MH	123101	1	ASTHMA	Asthma	GENERAL MEDICAL HISTORY	Respiratory system disorders	2003		ONGOING	2004-09-18
2	ABC123	MH	123101	2	FREQUENT HEADACHES	Headache	GENERAL MEDICAL HISTORY	Central and peripheral nervous system disorders	2004-07		ONGOING	2004-09-18
3	ABC123	MH	123101	3	BROKEN LEG	Bone fracture	GENERAL MEDICAL HISTORY	Musculoskeletal system disorders	2005-07-15	2005-08-31

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SDTM Example.Medical History