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Description

Demographics (DM) is a special-purpose domain that includes a set of essential standard variables that describe each subject in a clinical study. The collection of some demographics data is useful to perform simple analyses based upon population stratification.

Privacy concerns surrounding the DM and Subject Characteristics (SC) data were taken into account when these domains were created. For example, there are optional collection variables to collect the components of birthdate (e.g., BRTHDD, BRTHMO, BRTHYY); therefore, limited elements of birth day may be collected and later mapped to the tabulation variable BRTHDTC. This approach provides flexibility in categorizing some variables to facilitate compliance with local privacy issues.

Collection of Age vs. Date of Birth

It is recognized that applicants may collect the age or date of birth of the subject. In multiregional studies, applicants may need to enable the collection of either in order to comply with local regulations. But only one or the other should be collected for any given subject. TOBA-715 - Getting issue details... STATUS When only age is collected, the applicant is left with a window of uncertainty of, at most, 365 days. Although knowing the precise date of birth provides the ability to calculate accurately an age for any date, a precise (and complete) date of birth may be considered personally identifying information for some privacy oversight boards or government regulators.

Collect the date of birth to the extent that the local regulatory authorities will allow.

  • The best method is to collect a complete date of birth and derive age.
  • When there are privacy concerns with collecting the complete date of birth, the recommendation is to collect year of birth at a minimum.
  • In cases when neither of the above can be implemented (e.g., cultural or regional considerations) then age and age unit should be collected, and date of collection should be collected or derived from the visit date.
  • Use the AGETXT/CAGETXT variable in very rare cases, when only an age range or age description can be determined.

Date of birth should be implemented such that incomplete dates may be entered, as allowed by the EDC system.

TOBA-717 - Getting issue details... STATUS

Collection of Sex

Sex is the assemblage of properties or qualities by which male is distinguished from female. This is often collected  as it is useful to perform simple analyses based upon population stratification. TOBA-591 - Getting issue details... STATUS

Collection of Ethnicity and Race

Race and ethnicity will be collected per regulatory requirements.

Collect race if required for the protocol and not prohibited by local laws and regulations. The CDASH Model provides only 1 variable for Race. Applicants wishing to capture more than 1 race will need to create nonstandard variables to store the collection of the multiple races and map appropriately to the tabulation DM domain. Race Other has been included as a free-text field to capture responses. The use of this variable is optional. RACE is Recommended/Conditional (R/C) because some applicants prefer to derive values that are compliant with the codelist RACE (e.g., as derived from values collected in CRACE). For the collection of such added detail or granularity, as the applicant may require, CDASH Model provides the variables CRACE and CETHNIC, respectively.

Collection of Special Optional Fields in Demographics

TIG collection standards allow for collection of the Date of Informed Consent using the variable RFICDAT. (If an applicant chooses to collect informed consent using this variable, the data should not also be collected using DSSTDAT from the Disposition (DS) Domain.) The data from RFICDAT would then be mapped to the tabulation variable DSSTDTC and the companion variables (e.g., DSTERM, DSDECOD) must be populated accordingly.

The CDASH Model also defines a field for death date (DTHDAT) as a timing variable. It may be collected on any CRF deemed appropriate by the applicant. The tabulation variables DTHDTC and DTHFL are mapped to the DM domain during the dataset creation process. The collection field Death Date may be mapped to other tabulation domains (e.g., DS), as deemed appropriate by the applicant.

Data Collection Scenarios

This section describes 2 different data collection scenarios for the demographics domain. It is up to the applicant to determine which data collection scenario best meets the study needs:

  • Scenario 1: Birth date collection using 3 date fields:  This scenario includes date of birth collected as 3 fields (i.e., month, day, year).
  • Scenario 2: Birth date collection using a single date field: This scenario includes date of birth collected as a full date, in a single date field.  An example CRF is not shown for this scenario.


Specification

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
Special-PurposeDMBirth date collection using three date fieldsN/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 in the database or populated during tabulation dataset creation.
Special-PurposeDMBirth date collection using three date fieldsN/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.

Special-PurposeDMBirth date collection using three date fieldsN/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.

Special-PurposeDMBirth date collection using three date fieldsN/A4BRTHDDBirth DayDay of birth of the subject, in an unambiguous date format (e.g., DD).What is the subject's day of birth?Birth DayCharR/CRecord the subject's day of birth (e.g., 01 or 31).BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/ADay of Birth is the collected variable used for recording the day component of the Date of Birth. The applicant may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then tabulation variable AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.
Special-PurposeDMBirth date collection using three date fieldsN/A5BRTHMOBirth MonthMonth of birth of the subject, in an unambiguous date format (e.g., MMM).What is the subject's month of birth?Birth MonthCharR/CRecord the subject's month of birth [e.g., (in local language short month format) (JAN-DEC) or (ENE-DIE) or (JAN-DEZ), etc.].BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/AMonth of Birth is the collected variable used for recording the month component of the Date of Birth. The applicant may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE), if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.
Special-PurposeDMBirth date collection using three date fieldsN/A6BRTHYYBirth YearThe year of birth of the subject, in an unambiguous date format (e.g., YYYY).What is the subject's year of birth?Birth YearCharR/CRecord the subject's year of birth (e.g., YYYY, a four-digit year).BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/AYear of Birth is the collected variable used for recording the year component of the Date of Birth. The applicant may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.
Special-PurposeDMBirth date collection using three date fieldsN/A7BRTHTIMBirth TimeThe time of birth of the subject, in an unambiguous time format (e.g., hh:mm).What is the subject's time of birth?Birth TimeCharORecord the time of birth (as completely as possible).BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/AThe level of detail collected by Time of Birth may be necessary for analysis for some pediatric, natal, or neonatal studies. The applicant may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.
Special-PurposeDMBirth date collection using three date fieldsN/A8AGEAgeThe age of the subject, expressed in AGEU.What is the subject's age?AgeNumORecord age of the subject.AGEMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AIf age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (tabulation variable RFSTDTC). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.
Special-PurposeDMBirth date collection using three date fieldsN/A9AGEUAge UnitsUnits of time routinely used to express the age of a person.What is the age unit used?Age UnitCharORecord the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).AGEUMaps directly to the tabulation variable listed in the Tabulation Target column.(AGEU)N/AIf age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of "years").
Special-PurposeDMBirth date collection using three date fieldsN/A10DMDATDemographics Collection DateThe date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).What is the date of collection?Collection DateCharR/C

Record the date of collection using this format (DD-MON-YYYY). 

DMDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DMDTC in ISO 8601 format.N/AN/AThe date of collection may be determined from the date of visit; if so, a separate date field is not needed.
Special-PurposeDMBirth date collection using three date fieldsN/A11SEXSex

Sex of the subject. 

What is the sex of the subject?SexCharR/CRecord the appropriate sex (e.g., F (female), M (male).SEXMaps directly to the tabulation variable listed in the Tabulation Target column.(SEX)N/A

Collect the subject's sex or gender, This is a phenotypic assessment and not a genotypic assessment.

Special-PurposeDMBirth date collection using three date fieldsN/A12ETHNICEthnicityA social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityCharOStudy participants should self-report ethnicity, with ethnicity being asked about before race.ETHNICMaps directly to the tabulation variable listed in the Tabulation Target column.(ETHNIC)N/AWhen creating the DM form, regulatory guidance will be followed. Use ETHNIC when higher-level ethnicity categorizations are desired. Applicant may append a suffix to denote multiple collected ethnicities (e.g., ETHNIC1, ETHNIC2).
Special-PurposeDMBirth date collection using three date fieldsN/A13CETHNICCollected EthnicityA social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin, and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease.What is the ethnicity of the subject?EthnicityCharOStudy participants should self-report ethnicity, with ethnicity being asked about before race.SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity".(ETHNICC)N/AWhen creating the DM form, regulatory guidance will be followed. Use ETHNICC when more detailed ethnicity categorizations are desired. Applicants may append a suffix to denote multiple collected ethnicities (e.g., ETHNICC1, ETHNICC2).
Special-PurposeDMBirth date collection using three date fieldsN/A14RACERaceAn arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).Which of the following five racial designations best describes you? (More than one choice is acceptable.)RaceCharR/C

Study participants should self-report race, with race being asked about after ethnicity.

RACEMaps directly to the tabulation variable listed in the Tabulation Target column.(RACE)N/A

When creating the DM form, regulatory guidance will be followed. Use RACE when higher-level race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple  races for a subject by appending a suffix to denote multiple collected races (e.g., RACE1, RACE2) and populate RACE with the value MULTIPLE.

Special-PurposeDMBirth date collection using three date fieldsN/A15CRACECollected RaceAn arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).Which of the following racial designations best describes you? (More than 1 choice is acceptable.)RaceCharR/CStudy participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race".(RACEC)N/A

When creating the DM form, regulatory guidance will be followed. Use CRACE when more detailed race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g., CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.

Special-PurposeDMBirth date collection using three date fieldsN/A16RACEOTHRace OtherA free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.What was the other race?Specify Other RaceCharOIf none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free text field.SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER".N/AN/AWhen creating the DM form, regulatory guidance will be followed. Applicants may choose to include another value ("Specify, Other") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site.
Special-PurposeDMBirth date collection using a single date fieldN/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 in the database or populated during tabulation dataset creation.
Special-PurposeDMBirth date collection using a single date fieldN/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.

Special-PurposeDMBirth date collection using a single date fieldN/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.

Special-PurposeDMBirth date collection using a single date fieldN/A4BRTHDATBirth DateA subject's date of birth (with or without the time of birth). The complete Date of Birth is made from the temporal components of Birth Year, Birth Month, Birth Day, and Birth Time..What is the subject's date of birth?Birth DateCharR/CRecord the date of birth to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON-YYYY).BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/A

BRTHDAT is the collected field used for recording the full birth date. The applicant may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, selected components) is reported in the tabulation variable BRTHDTC in ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how age was determined and/or imputed for those birth dates collected with reduced precision.

Special-PurposeDMBirth date collection using a single date fieldN/A5

BRTHTIM

Birth TimeThe time of birth of the subject, in an unambiguous time format (e.g., hh:mm).What is the subject's time of birth?Birth TimeCharORecord the time of birth (as completely as possible).BRTHDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable BRTHDTC in ISO 8601 format.N/AN/AThe level of detail collected by Time of Birth may be necessary for analysis for some pediatric, natal, or neonatal studies. Applicants may choose to database the date of birth as a single variable (BRTHDAT), or as separate variables for each component of the date/time (BRTHYY, BRTHMO, BRTHDD, BRTHTIM). The applicant may choose a method based on database considerations, or for regulatory reasons. It is expected that what is collected for BRTHDAT (e.g., complete date, components) is reported in the tabulation variable BRTHDTC in the ISO 8601 format. If data are collected in a manner resulting in a reduced precision level, then AGE, if not collected on the CRF, should be derived using a documented algorithm that describes how the age was derived and/or imputed for those birth dates collected with reduced precision.
Special-PurposeDMBirth date collection using a single date fieldN/A6AGEAgeThe age of the subject, expressed in AGEU.What is the subject's age?AgeNumORecord age of the subject.AGEMaps directly to the tabulation variable listed in the Tabulation Target column.N/AN/AIf age is collected, it should be collected as a number and, to be correctly interpreted, the age value should be associated to a variable for the age unit. It may be necessary to know when the age was collected, as age may need to be recalculated for analysis, such as deriving age at a reference start time (tabulation variable RFSTDTC). BRTHDTC may not be available in all cases (due to subject privacy concerns). If AGE is collected, then it is recommended that the date of collection also be recorded, either separately or by association to the date of the visit.
Special-PurposeDMBirth date collection using a single date fieldN/A7AGEUAge UnitsUnits of time that are routinely used to express the age of a personWhat is the age unit used?Age UnitCharORecord the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.).AGEUMaps directly to the tabulation variable listed in the Tabulation Target column.(AGEU)N/AIf age is captured on the CRF, the age unit must be known to make the age value meaningful. The age unit might be collected on the CRF, in those cases where the protocol allows for any age group, or it may be pre-printed on the CRF (typically with the unit of "years").
Special-PurposeDMBirth date collection using a single date fieldN/A8DMDATDemographics Collection DateThe date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY).What is the date of collection?Collection DateCharR/CRecord the date of collection using this format (DD-MON-YYYY).DMDTCThis does not map directly to a tabulation variable. For the tabulation dataset, concatenate all collected DATE and TIME components and populate the tabulation variable DMDTC in ISO 8601 format.N/AN/AThe date of collection may be determined from the date of visit; if so, a separate date field is not needed.
Special-PurposeDMBirth date collection using a single date fieldN/A9SEXSexSex of the subject.What is the sex of the subject?SexCharR/CRecord the appropriate sex (e.g., F (female), M (male).SEXMaps directly to the tabulation variable listed in the Tabulation Target column.(SEX)N/ACollect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment.
Special-PurposeDMBirth date collection using a single date fieldN/A10ETHNICEthnicityA social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences and often a common genetic heritage; these features may be reflected in their experience of health and disease..Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityCharOStudy participants should self-report ethnicity, with ethnicity being asked about before race.ETHNICMaps directly to the tabulation variable listed in the Tabulation Target column.(ETHNIC)N/AWhen creating the DM form, regulatory guidance will be followed. Use ETHNIC when higher-level ethnicity categorizations are desired. Applicant may append a suffix to denote multiple collected ethnicities (e.g. ETHNIC1, ETHNIC2).
Special-PurposeDMBirth date collection using a single date fieldN/A11CETHNICCollected EthnicityA social group characterized by a distinctive social and cultural tradition maintained from generation to generation, a common history and origin and a sense of identification with the group; members of the group have distinctive features in their way of life, shared experiences, and often a common genetic heritage; these features may be reflected in their experience of health and disease.What is the ethnicity of the subject?EthnicityCharOStudy participants should self-report ethnicity, with ethnicity being asked about before race.SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "CETHNIC" and SUPPDM.QLABEL= "Collected Ethnicity".(ETHNICC)N/A

When creating the DM form, regulatory guidance will be followed. Use ETHNICC when more detailed ethnicity categorizations are desired. Applicants may append a suffix to denote multiple collected ethnicities (e.g. ETHNICC1, ETHNICC2).

Special-PurposeDMBirth date collection using a single date fieldN/A12RACERaceAn arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Center for Disease Control).Which of the following five racial designations best describes you? (More than one choice is acceptable.)RaceCharR/CStudy participants should self-report race, with race being asked about after ethnicity.RACEMaps directly to the tabulation variable listed in the Tabulation Target column.(RACE)N/A

When creating the DM form, regulatory guidance will be followed. Use RACE when higher level race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. RACE1, RACE2) and populate RACE with the value MULTIPLE.

Special-PurposeDMBirth date collection using a single date fieldN/A13CRACECollected RaceAn arbitrary classification based on physical characteristics; a group of persons related by common descent or heredity (US Centers for Disease Control).Which of the following racial designations best describes you? (More than one choice is acceptable.)RaceCharR/CStudy participants should self-report race, with race being asked about after ethnicity. (The FDA guidance suggests that individuals be permitted to designate a multiracial identity. Check all that apply at the time of collection).SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL when SUPPDM.QNAM = "CRACE" and SUPPDM.QLABEL="Collected Race".(RACEC)N/A

When creating the DM form, regulatory guidance will be followed. Use CRACE when more detailed race categorizations are desired. If multiple races are collected, an alternate applicant-defined variable structure would be required. Applicants may record multiple self-reported races for a subject by appending a suffix to denote multiple collected races (e.g. CRACE1, CRACE2) and populate CRACE with the value MULTIPLE.

Special-PurposeDMBirth date collection using a single date fieldN/A14RACEOTHRace OtherA free-text field to be used when none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values.What was the other race?Specify Other RaceCharOIf none of the pre-printed values for RACE are applicable or if another, unprinted selection should be added to those pre-printed values, record the value in this free-text field.SUPPDM.QVALThis does not map directly to a tabulation variable. This information could be represented in a SUPPDM dataset as the value of SUPPDM.QVAL where SUPPDM.QNAM = "RACEOTH" and SUPP.QLABEL="RACE OTHER".N/AN/AWhen creating the DM form, regulatory guidance will be followed. Applicants may choose to include another value ("Specify, Other") with a free-text field for extending the list of values. The RACEOTH variable contains the free text added by the site.

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Content: For variable Birth date collection using three date fields / N/A / DMDAT, non-ASCII characters (highlighted text in table), found in Case Report Form Completion Instructions; offending characters list: [ ]
  • Content: For variable Birth date collection using three date fields / N/A / SEX, non-ASCII characters (highlighted text in table), found in DRAFT Collection Definition; offending characters list: [ ]
  • Content: For variable Birth date collection using three date fields / N/A / RACE, non-ASCII characters (highlighted text in table), found in Implementation Notes; offending characters list: [ ]


Assumptions

  1. The collection DM domain is a special-purpose domain that collects specific data elements that are mapped to the tabulation DM domain. Additional data elements that are not within the scope of the demographics must be mapped to other domains.




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