SDTM.MH

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	MH	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	MH	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	MH	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	MH	MHSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	MH	MHGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	MH	MHREFID	Reference ID	Char		Identifier	Perm	Internal or external medical history identifier.
7	MH	MHSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Medical History page.
8	MH	MHTERM	Reported Term for the Medical History	Char		Topic	Req	Verbatim or preprinted CRF term for the medical condition or event.
9	MH	MHMODIFY	Modified Reported Term	Char		Synonym Qualifier	Perm	If MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text.
10	MH	MHDECOD	Dictionary-Derived Term	Char		Synonym Qualifier	Perm	Dictionary-derived text description of MHTERM or MHMODIFY. Equivalent to the Preferred Term (PT in MedDRA). The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes.
11	MH	MHCAT	Category for Medical History	Char		Grouping Qualifier	Perm	Used to define a category of related records. Examples: CARDIAC or GENERAL
12	MH	MHSCAT	Subcategory for Medical History	Char		Grouping Qualifier	Perm	A further categorization of the condition or event.
13	MH	MHPRESP	Medical History Event Pre-Specified	Char	C66742	Variable Qualifier	Perm	A value of "Y" indicates that this medical history event was pre-specified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms)
14	MH	MHOCCUR	Medical History Occurrence	Char	C66742	Record Qualifier	Perm	Used when the occurrence of specific medical history conditions is solicited to indicate whether or not (Y/N) a medical condition (MHTERM) had ever occurred. Values are null for spontaneously reported events.
15	MH	MHSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	The status indicates that the pre-specified question was not asked/answered.
16	MH	MHREASND	Reason Medical History Not Done or Not Occurred	Char		Record Qualifier	Perm	Reason the question was not asked/answered or an intervention did not occur. Used in conjunction with negation indicators --STAT of 'NOT DONE' or --OCCUR of 'N'
17	MH	MHBODSYS	Body System or Organ Class	Char		Record Qualifier	Perm	Dictionary-derived. Body system or organ class that is involved in an event or measurement from a standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor's analyses and summary tables which may not necessarily be the primary SOC.
18	MH	MHDTC	Date/Time of History Collection	Char	ISO 8601	Timing	Perm
19	MH	MHSTDTC	Start Date/Time of Medical History Event	Char	ISO 8601	Timing	Perm
20	MH	MHENDTC	End Date/Time of Medical History Event	Char	ISO 8601	Timing	Perm
21	MH	MHDY	Study Day of History Collection	Num		Timing	Perm	1. Study day of medical history collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
22	MH	MHENRF	End Relative to Reference Period	Char	C66728	Timing	Perm	Describes the end of the event relative to the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics)
23	MH	MHENRTPT	End Relative to Reference Time Point	Char		Timing	Perm	Identifies the end of the event as being before or after the reference time point defined by variable MHENTPT.
24	MH	MHENTPT	End Reference Time Point	Char		Timing	Perm	Description or date/time in ISO 8601 character format of the reference point referred to by MHENRTPT. Examples: "2003-12-25" or "VISIT 2".