| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | MH | 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. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a Medical History CRF 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). | Perm |
| MHEVDTYP | Medical History Event Date Type | Char | (MHEDTTYP) | 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", "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 | (NY) | Variable Qualifier | A value of "Y" indicates that this medical history event was prespecified 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 | (NY) | Record Qualifier | Used when the occurrence of specific medical history conditions is solicited, to indicate whether ("Y"/"N") a medical condition (MHTERM) had ever occurred. Values are null for spontaneously reported events. | Perm |
| MHSTAT | Completion Status | Char | (ND) | Record Qualifier | The status indicates that the prespecified question was not asked/answered. | Perm |
| MHREASND | Reason Medical History Not Collected | Char |
| Record Qualifier | Describes the reason why data for a prespecified 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 standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the applicant's analyses and summary tables which may not necessarily be the primary SOC. | Perm |
| 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 | (EPOCH) | Timing | Epoch associated with the start date/time of the medical history event. | Perm |
| MHDTC | Date/Time of History Collection | Char | ISO 8601 datetime or interval | 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 | ISO 8601 datetime or interval | 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 | ISO 8601 datetime or interval | 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 day. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm |
| MHENRF | End Relative to Reference Period | Char | (STENRF) | Timing | Describes the end of the event relative to the applicant-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). | Perm |
| MHENRTPT | End Relative to Reference Time Point | Char | (STENRF) | Timing | Identifies the end of the event as being before or after the reference time point defined by variable MHENTPT. | 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", "VISIT 2". | Perm |