| Observation Class | Domain | Data Collection Scenario | Implementation Options | Order Number | Collection Variable | Collection Variable Label | DRAFT Collection Definition | Question Text | Prompt | Data Type | Collection Core | Case Report Form Completion Instructions | Tabulation Target | Mapping Instructions | Controlled Terminology Codelist Name | Subset Controlled Terminology/CDASH Codelist Name | Implementation Notes |
| Events | MH | N/A | N/A | 1 | STUDYID | Study Identifier | A unique identifier for a study. | What is the study identifier? | [Protocol/Study] | Char | HR | N/A | STUDYID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Although this field is not typically captured on a CRF, it should be displayed clearly on the CRF and/or in the EDC system. This field can be included into the database or populated during tabulation dataset creation. |
| Events | MH | N/A | N/A | 2 | SITEID | Study Site Identifier | A unique identifier for a site within a study. | What is the site identifier? | Site (Identifier) | Char | HR | N/A | DM.SITEID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically pre-printed in the header of each CRF page for single-site studies. For studies with multiple sites, this field may be left blank so that the number can be recorded by the site, or it may be pre-printed on the CRFs that are shipped to each site. EDC: This should be pre-populated. |
| Events | MH | N/A | N/A | 3 | SUBJID | Subject Identifier for the Study | A unique subject identifier within a site and a study. | What [is/was] the (study) [subject/participant] identifier? | [Subject/Participant] (Identifier) | Char | HR | Record the identifier for the subject. | DM.SUBJID | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Paper: This is typically recorded in the header of each CRF page. EDC: The subject identifiers may be system-generated. This collection variable is typically collected in all domains. However, this collection variable is populated only in the tabulation DM domain. |
| Events | MH | N/A | N/A | 4 | MHYN | Any Medical History Event | An indication of whether there was any medical history to report. | Were any medical conditions or events reported?; Has the subject had any medical conditions or events? | Any Medical History | Char | O | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | N/A | Does not map to a tabulation variable. | (NY) | N/A | The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank. |
| Events | MH | N/A | N/A | 5 | MHCAT | Category for Medical History | A grouping of topic-variable values based on user-defined characteristics. | What was the category of the medical history? | [Medical History Category]; NULL | Char | R/C | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | MHCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology (e.g., CARDIAC, GENERAL). This would most commonly be either a heading or a pre-printed category value on the CRF, not a question to which the site would provide an answer. If a question is asked, the response would typically be an applicant-defined codelist. If the form is laid out as a grid, then words such as "Category" can be included as the column header. This would be used when specific medical history is captured, in addition to the general medical history. |
| Events | MH | N/A | N/A | 6 | MHSCAT | Subcategory for Medical History | A sub-division of the MHCAT values based on user-defined characteristics. | What was the subcategory of the medical history? | [Medical History Subcategory]; NULL | Char | O | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | MHSCAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicant-defined controlled terminology. This would most commonly be pre-printed on the CRF or screen and pre-populated in the data management system. This is not typically a question to which the site would provide an answer. Typically would be used when specific medical history (e.g., disease diagnosis) is captured, in addition to the general medical history. MHSCAT can only be used if there is an MHCAT, and it must be a subcategorization of MHCAT. |
| Events | MH | N/A | N/A | 7 | MHDAT | Medical History Collection Date | The date on which the medical history was collected, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What was the date the medical history was collected? | Collection Date | Char | O | Record the date on which the medical history was collected using this format (DD-MON-YYYY). | MHDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable MHDTC in ISO 8601 format. | N/A | N/A | This should be a complete date. The date of collection may be determined from a collected visit date. |
| Events | MH | N/A | N/A | 8 | MHSPID | MH Applicant-Defined Identifier | A applicant-defined identifier. This is typically used for pre-printed or auto-generated numbers on the CRF, or any other type of identifier that does not already have a defined identifier field. | [Applicant-defined question] | [Applicant defined] | Char | O | If collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier. | MHSPID | Maps directly to the tabulation variable listed in the Tabulation Target column. May be used to create RELREC to link this record with a record in another domain. | N/A | N/A | Because SPID is a applicant-defined identifier, conformance to Question Text or Item Prompt is not applicable. Typically used as an identifier in a data query to communicate clearly to the site the specific record in question or to reconcile concomitant medications and/or procedure records with MH. May be used to record pre-printed number (e.g. line number, record number) on the CRF. This field may be populated by the applicant's data collection system. If CMMHNO or PRMHNO is used, this is the identifier to which CMMHNO or PRMHNO refers. |
| Events | MH | N/A | N/A | 9 | MHEVDTYP | Medical History Event Date Type | Specifies the aspect of the medical condition or event by which MHSTDTC and/or MHENDTC is defined. | What was the medical history event date type? | Medical History Event Date Type | Char | O | The instructions depend upon the format of the CRF. Applicants may print these values on the CRF or use them as defaulted or hidden text. | MHEVDTYP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (MHEDTTYP) | N/A | The type of start/ and or end date (e.g.,, DIAGNOSIS, SYMPTOMS, RELAPSE, INFECTION). It is not related to the trial's condition. This date type cannot be a PRIMARY DIAGNOSIS, SECONDARY DIAGNOSIS because these terms do not define the date type. |
| Events | MH | N/A | N/A | 10 | MHTERM | Reported Term for the Medical History | The reported or pre-specified name of the medical condition or event. | What is the medical condition or event term? | Medical History Term | Char | HR | Record all relevant medical conditions or events, as defined in the protocol. Record only 1 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. | MHTERM | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | Applicants should collect all relevant medical conditions or events, as defined in the protocol. It is a best practice for Applicants to collect all relevant history of surgeries or procedures using the associated diagnosis in the MH domain, while reporting relevant surgeries and procedures in the tabulation PR domain. Applicants should provide instructions on how surgeries and procedures will be handled based on the protocol requirements. Information on specified surgeries or procedures should be collected in the PR domain. |
| Events | MH | N/A | N/A | 11 | MHOCCUR | Medical History Occurrence | An indication of whether a pre-specified medical condition/event or a group of medical conditions/events occurred when information about the occurrence of a specific event is solicited. | Did the subject have [prespecified medical condition/event/group of medical conditions]; Is the [prespecified medical occurring]? | [Medical condition/Event] | Char | O | Indicate if [specific medical condition/event] has occurred/is occurring by checking Yes or No. | MHOCCUR | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | MHOCCUR is used to report the occurrence of specified medical conditions or events. MHOCCUR is not used if the medical conditions or events are collected on the CRF in a manner that requires spontaneously free-text response. The site should be able to indicate that the question was not asked or answered. |
| Events | MH | N/A | N/A | 12 | MHPRESP | Medical History Event Prespecified | An indication that a specific event, or group of events, are pre-specified on a CRF. | N/A | N/A | Char | O | N/A | MHPRESP | Maps directly to the tabulation variable listed in the Tabulation Target column. | (NY) | N/A | A hidden field on a CRF defaulted to "Y", or added during the tabulation dataset creation when the medical condition or event is prespecified. Null for spontaneously reported events. If a study collects both pre-specified medical history and free-text events, the value of MHPRESP should be "Y" for all pre-specified events and null for medical conditions or events reported as free text. MHPRESP is a permissible and may be omitted from the tabulation dataset if all events were collected as free text. |
| Events | MH | N/A | N/A | 13 | MHPRIOR | Prior Medical History Event | An indication of whether the event occurred prior to study start. | Did the medical condition or event start prior to [MHSTTPT]?; Did the medical condition or event start prior to study start? | Prior to [MHSTTPT]; Prior to Study | Char | O | Check if the medical condition or event started [before the study]. | MHSTRTPT; MHSTRF | This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable such as MHSTRF or MHSTRTPT. When populating MHSTRF, or MHSTRTPT, if the value of the collection field MHPRIOR is "Y" a value from the CDISC CT (STENRF) may be used. When MHPRIOR refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable MHSTRF should be populated. When MHPRIOR is compared to another time point, the tabulation variables MHSTRTPT and MHSTTPT should be used. Note: MHSTRTPT must refer to the time-point anchor described in MHSTTPT. | (NY) | N/A | Applicants may collect this information rather than start dates. |
| Events | MH | N/A | N/A | 14 | MHONGO | Ongoing Medical History Event | Indication the medical condition or event is ongoing when no end date is provided. | Is the medical condition or event ongoing (as of the [study-specific timepoint or period])? | Ongoing (as of the [study-specific timepoint or period]) | Char | O | Record the medical condition or event as ongoing ("Y") if it has not ended at the time of data collection. If the medical condition or event is ongoing, the end date should be left blank. | MHENRF; MHENRTPT | This does not map directly to a tabulation variable. May be used to populate a value into a tabulation relative timing variable such as MHENRF or MHENRTPT. When populating MHENRF, if the value of MHONGO is "Y", the value of "DURING", "AFTER" or "DURING/AFTER" may be used. When populating MHENRTPT, if the value of MHONGO is "Y", the value of "ONGOING" may be used. When MHONGO refers to the Study Reference Period (defined in DM.RFSTDTC to DM.RFENDTC) the tabulation variable MHENRF should be populated. When MHONGO is compared to another time point, the tabulation variables MHENRTPT and MHENTPT should be used. Note: MHENRTPT must refer to a time-point anchor described in MHENTPT. | (NY) | N/A | Completed to indicate that the condition has not resolved at the time of data collection. It is expected that every reported condition has either an end date or the Ongoing field is populated, but not both. |
| Events | MH | N/A | N/A | 15 | MHCTRL | MH Disease or Symptom Under Control | Indication of whether the medical condition or event is under control at the time of data collection. | Is the medical condition or event under control? | Medical Condition Under Control | Char | O | Select the most appropriate response. | SUPPMH.QVAL | This does not map directly to a tabulation variable. This information could be represented in a SUPPMH dataset as the value of SUPPMH.QVAL where SUPPMH.QNAM ="MHCTRL" and SUPPMH.LABEL="Medical Condition Under Control". | (NY) | N/A | MHCTRL is not defined in the tabulation MH domain. If collected, it should be represented in the SUPPMH dataset. If MHCTRL is collected, the applicant must provide information on the relative timeframe. Generally, MHDAT is collected or determined using the visit date of the collection to indicate this is the subject's status at the time of data collection. |
| Events | MH | N/A | N/A | 16 | MHSTDAT | Medical History Event Start Date | The start date of medical history event or condition, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What [is/was] the [medical event or condition/category of the event] start date? | Start Date | Char | O | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | MHSTDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected START DATE and TIME components and populate the tabulation variable MHSTDTC in ISO 8601 format. | N/A | N/A | The applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year). |
| Events | MH | N/A | N/A | 17 | MHENDAT | Medical History Event End Date | The end date of medical history event or condition, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What[is/was] the[medical event or condition/category of the event] end date? | End Date | Char | O | Record the end date of the medical event or condition using this format (DD-MON-YYYY). | MHENDTC | This does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected END DATE and TIME components and populate the tabulation variable MHENDTC in ISO 8601 format. | N/A | N/A | The applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year). |
| Events | MH | N/A | N/A | 18 | MHLOC | Medical History Event Location | A description of the anatomical location relevant for the medical condition or event. | What was the anatomical location of the medical condition or event? | Anatomical Location | Char | O | Indicate the anatomical location of the medical event or condition. | MHLOC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LOC) | N/A | Collected or pre-printed when the applicant needs to identify the specific anatomical location (e.g., ARM for skin rash). Could be a defaulted or hidden field on the CRF for prespecified [MHTERM/Event Topic]. Applicants may collect the data using a subset list of controlled terminology on the CRF. LAT, DIR, PORTOT are used to further describe the anatomical location. |
| Events | MH | N/A | N/A | 19 | MHLAT | Medical History Event Laterality | Qualifier for anatomical location, further detailing the side of the body relevant for the event. | What was the side of the anatomical location of the medical condition or event? | Side | Char | O | Record the side of the anatomical location of the medical event. | MHLAT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (LAT) | N/A | May be pre-printed or collected when the applicant needs to identify the specific side of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | MH | N/A | N/A | 20 | MHDIR | Medical History Directionality | Qualifier further detailing the position of the anatomical location, relative to the center of the body, organ, or specimen. | What was the directionality of the anatomical location of the medical condition or event? | Directionality | Char | O | Record the directionality of the anatomical location of the medical event. | MHDIR | Maps directly to the tabulation variable listed in the Tabulation Target column. | (DIR) | N/A | May be pre-printed or collected when the applicant needs to identify the directionality of the anatomical location. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | MH | N/A | N/A | 21 | MHPORTOT | MH Event Location Portion or Totality | Qualifier for anatomical location, further detailing the distribution (i.e., arrangement of, apportioning of). | What was the portion or totality of the anatomical location of the of the medical condition or event? | Portion or Totality | Char | O | Indicate the portion or totality anatomical location of the medical event. | MHPORTOT | Maps directly to the tabulation variable listed in the Tabulation Target column. | (PORTOT) | N/A | Collected when the applicant needs to identify the specific portionality for the anatomical locations. Applicants may collect the data using a subset list of controlled terminology on the CRF. |
| Events | MH | N/A | N/A | 22 | MHMODIFY | MH Modified Reported Term | If the value for MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text. | N/A | N/A | Char | O | N/A | MHMODIFY | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is not a data collection field that would appear on the CRF. Applicants will populate this through the coding process. |
| Events | MH | N/A | N/A | 23 | MHDECOD | MH Dictionary-Derived Term | The dictionary text description of MHTERM or the modified topic variable (MH MODIFY), if applicable. | N/A | N/A | Char | O | N/A | MHDECOD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This is typically not a data collection field that will appear on the CRF. Applicants will populate this through the coding process. Equivalent to the Preferred Term (PT in MedDRA). |
| Events | MH | N/A | N/A | 24 | MHLLT | Medical History Event Lowest Level Term | The dictionary-derived text description of the lowest level term. | N/A | N/A | Char | O | N/A | MHLLT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 25 | MHLLTCD | MH Event Lowest Level Term Code | The dictionary-derived code for the lowest level term. | N/A | N/A | Num | O | N/A | MHLLTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 26 | MHPTCD | MH Event Preferred Term Code | The dictionary-derived code for the preferred term. | N/A | N/A | Num | O | N/A | MHPTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 27 | MHHLT | Medical History Event High Level Term | The dictionary-derived text description of the high level term for the primary system organ class (SOC). | N/A | N/A | Char | O | N/A | MHHLT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 28 | MHHLTCD | MH Event High Level Term Code | The dictionary-derived code for the high level term for the primary system organ class (SOC). | N/A | N/A | Num | O | N/A | MHHLTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 29 | MHHLGT | MH Event High Level Group Term | The dictionary-derived text description of the high level group term for the primary system organ class (SOC). | N/A | N/A | Char | O | N/A | MHHLGT | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 30 | MHHLGTCD | MH Event High Level Group Term Code | The dictionary-derived code for the high level group term for the primary system organ class (SOC). | N/A | N/A | Num | O | N/A | MHHLGTCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. |
| Events | MH | N/A | N/A | 31 | MHSOC | MH Event Primary System Organ Class | The dictionary-derived text description of the primary system organ class (SOC). | N/A | N/A | Char | O | N/A | MHSOC | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MH BODSYS if the primary SOC was used for analysis. |
| Events | MH | N/A | N/A | 32 | MHSOCCD | MH Event Primary System Organ Class Code | The dictionary-derived code for the primary system organ class (SOC). | N/A | N/A | Num | O | N/A | MHSOCCD | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | This field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding. Will be the same as MHBDSYCD if the primary SOC was used for analysis. |