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TIG v1.0 Metadata Check for CDASH Domain Specification Table Beta 2

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Observation ClassDomainData Collection ScenarioImplementation OptionsOrder NumberCollection VariableCollection Variable LabelDRAFT Collection DefinitionQuestion TextPromptData TypeCollection CoreCase Report Form Completion InstructionsTabulation TargetMapping InstructionsControlled Terminology Codelist NameSubset Controlled Terminology/CDASH Codelist NameImplementation Notes
EventsMHN/AN/A1STUDYIDStudy IdentifierA unique identifier for a study.What is the study identifier?[Protocol/Study]CharHRN/ASTUDYIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AAlthough 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.
EventsMHN/AN/A2SITEIDStudy Site IdentifierA unique identifier for a site within a study.What is the site identifier?Site (Identifier)CharHRN/ADM.SITEIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

EventsMHN/AN/A3SUBJIDSubject Identifier for the StudyA unique subject identifier within a site and a study.What [is/was] the (study) [subject/participant] identifier?[Subject/Participant] (Identifier)CharHRRecord the identifier for the subject.DM.SUBJIDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/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.

EventsMHN/AN/A4MHYNAny Medical History EventAn 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 HistoryCharOIndicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF.N/ADoes not map to a tabulation variable.(NY)N/AThe 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.
EventsMHN/AN/A5MHCATCategory for Medical HistoryA grouping of topic-variable values based on user-defined characteristics.What was the category of the medical history?[Medical History Category]; NULLCharR/CIf collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.MHCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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.
EventsMHN/AN/A6MHSCATSubcategory for Medical HistoryA sub-division of the MHCAT values based on user-defined characteristics.What was the subcategory of the medical history?[Medical History Subcategory]; NULLCharOIf collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.MHSCATMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicant-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.
EventsMHN/AN/A7MHDATMedical History Collection DateThe 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 DateCharORecord the date on which the medical history was collected using this format (DD-MON-YYYY).MHDTCThis 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/AN/AThis should be a complete date. The date of collection may be determined from a collected visit date.
EventsMHN/AN/A8MHSPIDMH Applicant-Defined IdentifierA 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]CharOIf collected on the CRF, applicant may insert instructions to ensure each record has a unique identifier.MHSPIDMaps 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/AN/ABecause 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.
EventsMHN/AN/A9MHEVDTYPMedical History Event Date TypeSpecifies 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 TypeCharOThe instructions depend upon the format of the CRF. Applicants may print these values on the CRF or use them as defaulted or hidden text.MHEVDTYPMaps directly to the tabulation variable listed in the Tabulation Target column.(MHEDTTYP)N/AThe 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.
EventsMHN/AN/A10MHTERMReported Term for the Medical HistoryThe reported or pre-specified name of the medical condition or event.What is the medical condition or event term?Medical History TermCharHRRecord 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.MHTERMMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AApplicants 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.
EventsMHN/AN/A11MHOCCURMedical History OccurrenceAn 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]CharOIndicate if [specific medical condition/event] has occurred/is occurring by checking Yes or No.MHOCCURMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AMHOCCUR 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.
EventsMHN/AN/A12MHPRESPMedical History Event PrespecifiedAn indication that a specific event, or group of events, are pre-specified on a CRF.N/AN/ACharON/AMHPRESPMaps directly to the tabulation variable listed in the Tabulation Target column.(NY)N/AA 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.
EventsMHN/AN/A13MHPRIORPrior Medical History EventAn 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 StudyCharOCheck if the medical condition or event started [before the study].MHSTRTPT; MHSTRFThis 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/AApplicants may collect this information rather than start dates.
EventsMHN/AN/A14MHONGOOngoing Medical History EventIndication 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])CharORecord 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/ACompleted 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.
EventsMHN/AN/A15MHCTRLMH Disease or Symptom Under ControlIndication 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 ControlCharOSelect the most appropriate response.SUPPMH.QVALThis 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/AMHCTRL 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.
EventsMHN/AN/A16MHSTDATMedical History Event Start DateThe 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 DateCharORecord the start date of the medical event or condition using this format (DD-MON-YYYY).MHSTDTCThis 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/AN/AThe applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year).
EventsMHN/AN/A17MHENDATMedical History Event End DateThe 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 DateCharORecord the end date of the medical event or condition using this format (DD-MON-YYYY).MHENDTCThis 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/AN/AThe applicant may choose to capture a complete date or any variation thereof (e.g., month and year, year).
EventsMHN/AN/A18MHLOCMedical History Event LocationA description of the anatomical location relevant for the medical condition or event.What was the anatomical location of the medical condition or event?Anatomical LocationCharOIndicate the anatomical location of the medical event or condition.MHLOCMaps directly to the tabulation variable listed in the Tabulation Target column.(LOC)N/ACollected 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.
EventsMHN/AN/A19MHLATMedical History Event LateralityQualifier 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?SideCharORecord the side of the anatomical location of the medical event.MHLATMaps directly to the tabulation variable listed in the Tabulation Target column.(LAT)N/AMay 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.
EventsMHN/AN/A20MHDIRMedical History DirectionalityQualifier 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?DirectionalityCharORecord the directionality of the anatomical location of the medical event.MHDIRMaps directly to the tabulation variable listed in the Tabulation Target column.(DIR)N/AMay 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.
EventsMHN/AN/A21MHPORTOTMH Event Location Portion or TotalityQualifier 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 TotalityCharOIndicate the portion or totality anatomical location of the medical event.MHPORTOTMaps directly to the tabulation variable listed in the Tabulation Target column.(PORTOT)N/ACollected 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.
EventsMHN/AN/A22MHMODIFYMH Modified Reported TermIf the value for MHTERM is modified to facilitate coding, then MHMODIFY will contain the modified text.N/AN/ACharON/AMHMODIFYMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis is not a data collection field that would appear on the CRF. Applicants will populate this through the coding process.
EventsMHN/AN/A23MHDECODMH Dictionary-Derived TermThe dictionary text description of MHTERM or the modified topic variable (MH MODIFY), if applicable.N/AN/ACharON/AMHDECODMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis 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).
EventsMHN/AN/A24MHLLTMedical History Event Lowest Level TermThe dictionary-derived text description of the lowest level term.N/AN/ACharON/AMHLLTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A25MHLLTCDMH Event Lowest Level Term CodeThe dictionary-derived code for the lowest level term.N/AN/ANumON/AMHLLTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A26MHPTCDMH Event Preferred Term CodeThe dictionary-derived code for the preferred term.N/AN/ANumON/AMHPTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A27MHHLTMedical History Event High Level TermThe dictionary-derived text description of the high level term for the primary system organ class (SOC).N/AN/ACharON/AMHHLTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A28MHHLTCDMH Event High Level Term CodeThe dictionary-derived code for the high level term for the primary system organ class (SOC).N/AN/ANumON/AMHHLTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A29MHHLGTMH Event High Level Group TermThe dictionary-derived text description of the high level group term for the primary system organ class (SOC).N/AN/ACharON/AMHHLGTMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A30MHHLGTCDMH Event High Level Group Term CodeThe dictionary-derived code for the high level group term for the primary system organ class (SOC).N/AN/ANumON/AMHHLGTCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis field does not typically appear on the CRF. Applicants will populate this through the coding process. This is applicable to items using MedDRA coding.
EventsMHN/AN/A31MHSOCMH Event Primary System Organ ClassThe dictionary-derived text description of the primary system organ class (SOC).N/AN/ACharON/AMHSOCMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis 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.
EventsMHN/AN/A32MHSOCCDMH Event Primary System Organ Class CodeThe dictionary-derived code for the primary system organ class (SOC).N/AN/ANumON/AMHSOCCDMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AThis 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.

Metadata Checks Findings

Metadata Check User Macros FAQ
  • For variable N/A / N/A / MHPRIOR, MHSTRTPT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHPRIOR, MHSTRF is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHLOC, MHLOC is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHLAT, MHLAT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHDIR, MHDIR is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHPORTOT, MHPORTOT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHLLT, MHLLT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHLLTCD, MHLLTCD is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHPTCD, MHPTCD is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHHLT, MHHLT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHHLTCD, MHHLTCD is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHHLGT, MHHLGT is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHHLGTCD, MHHLGTCD is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHSOC, MHSOC is a not a recognized tabulation variable in Tabulation Target
  • For variable N/A / N/A / MHSOCCD, MHSOCCD is a not a recognized tabulation variable in Tabulation Target

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