Medical History

The Medical History (MH) domain is based on the Events General Observation class. The MH domain is used to represent information collected about medical conditions that started prior to the start of the study. The study timepoint at which events stop being pre-study events (medical history) is determined by the sponsor according to the requirements of the study. However, the "stop" timepoint may be no earlier than the date of informed consent (which is recorded for each subject in the RFICDTC variable in the DM domain) and no later than the start date of the Study Reference Period (which is recorded for each subject in the RFSTDTC variable in the DM dataset).  The timepoint is usually identifiable as the point at which medical history information is collected; medical conditions starting after the collection of medical history information are often considered to be on-study events. Note that the relative timing variables used to represent medical history events as being "prior" or "ongoing" will depend on whether the collection of medical history information coincides with the start of the study reference period. 

Example

This is an example Medical History CRF. This CRF collects verbatim descriptions of any medical conditions or events experienced by the subject. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event was ongoing.

CDASH MH Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
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	MHYN	N/A	Not Submitted	(NY)	No;Yes

Section 2 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
2	What is the category?	Medical History Category		Text	MHCAT	MHCAT			GENERAL MEDICAL HISTORY
3	What is the medical condition or event identifier?	MH Number	Applicant-Defined CRF Completion Instructions	Text	MHSPID	MHSPID
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	MHTERM
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	MHSTDAT	MHSTDTC
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	MHONGO	MHENRF/  MHENRTPT	MHENRF or  MHENRTPT	(NY)	No;Yes
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	MHENDAT

This is an example SDTM dataset used to represent the medical history collected on the above CRF. This CRF was designed to allow the applicant to use either MHENRF or MHENRTPT to represent an event that was ongoing. This SDTM dataset uses MHENRTPT. (For more information, see Section 2.8.7.6, Representing References and Relative Timing.)

mh.xpt

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 Medical History CRF. MHENTPT displays the reference date for MHENRTPT (i.e., the date the information was collected). If "Yes" was specified for Ongoing, MHENRTPT = "ONGOING"; if "No" was checked, MHENRTPT = "BEFORE".

Row 3:

Displays the start and end date of the reported event.

mh.xpt

mh.xpt

Row	STUDYID	DOMAIN	USUBJID	MHSEQ	MHSPID	MHTERM	MHDECOD	MHCAT	MHBODSYS	MHSTDTC	MHENDTC	MHENRTPT	MHENTPT
1	ABC123	MH	123101	1	01	ASTHMA	Asthma	GENERAL MEDICAL HISTORY	Respiratory system disorders	2003		ONGOING	2004-09-18
2	ABC123	MH	123101	2	02	FREQUENT HEADACHES	Headache	GENERAL MEDICAL HISTORY	Central and peripheral nervous system disorders	2004-07		ONGOING	2004-09-18
3	ABC123	MH	123101	3	03	BROKEN LEG	Bone fracture	GENERAL MEDICAL HISTORY	Musculoskeletal system disorders	2005-07-15	2005-08-31

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