VariableName VariableLabel Type Role Note Core
STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
DOMAIN Domain Abbreviation Char Identifier Two-character abbreviation for the domain. Req
USUBJID Unique Subject Identifier Char Identifier Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Req
MHSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
MHGRPID Group ID Char Identifier Used to tie together a block of related records in a single domain for a subject. Perm
MHREFID Reference ID Char Identifier Internal or external medical history identifier. Perm
MHSPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Medical History page. Perm
MHTERM Reported Term for the Medical History Char Topic Verbatim or preprinted CRF term for the medical condition or event. Req
MHMODIFY Modified Reported Term Char Synonym Qualifier If MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text. Perm
MHDECOD Dictionary-Derived Term Char Synonym Qualifier 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 external codelist element in the Define-XML document. Perm
MHEVDTYP Medical History Event Date Type Char Variable Qualifier Specifies the aspect of the medical condition or event by which MHSTDTC and/or the MHENDTC is defined. Examples: "DIAGNOSIS", "SYMPTOMS", "RELAPSE", "INFECTION". Perm
MHCAT Category for Medical History Char Grouping Qualifier Used to define a category of related records. Examples: "CARDIAC" or "GENERAL". Perm
MHSCAT Subcategory for Medical History Char Grouping Qualifier A further categorization of the condition or event. Perm
MHPRESP Medical History Event Pre-Specified Char Variable Qualifier 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). Perm
MHOCCUR Medical History Occurrence Char Record Qualifier 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. Perm
MHSTAT Completion Status Char Record Qualifier The status indicates that the pre-specified question was not asked/answered. Perm
MHREASND Reason Medical History Not Collected Char Record Qualifier Describes the reason why data for a pre-specified condition was not collected. Used in conjunction with MHSTAT when value is "NOT DONE". Perm
MHBODSYS Body System or Organ Class Char Record Qualifier Dictionary-derived. Body system or organ class that is involved in an event or measurement from a Perm
        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.  
TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm for the Element in which the assessment was made. Perm
EPOCH Epoch Char Timing Epoch associated with the start date/time of the medical history event. Perm
MHDTC Date/Time of History Collection Char Timing Collection date and time of the medical history observation represented in ISO 8601 character format. Perm
MHSTDTC Start Date/Time of Medical History Event Char Timing Start date/time of the medical history event represented in ISO 8601 character format. Perm
MHENDTC End Date/Time of Medical History Event Char Timing End date/time of the medical history event. Perm
MHDY Study Day of History Collection Num Timing Study day of medical history collection, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. Perm
MHENRF End Relative to Reference Period Char Timing 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). Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables. Perm
MHENRTPT End Relative to Reference Time Point Char Timing Identifies the end of the event as being before or after the reference time point defined by variable MHENTPT. Not all values of the codelist are allowable for this variable. See Section 4.4.7, Use of Relative Timing Variables Perm
MHENTPT End Reference Time Point Char Timing Description or date/time in ISO 8601 character format of the reference point referred to by MHENRTPT. Examples: "2003-12-25" or "VISIT 2". Perm