| 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 |
| Special-Purpose | DM | Birth date collection using three date fields | 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 in the database or populated during tabulation dataset creation. |
| Special-Purpose | DM | Birth date collection using three date fields | 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. |
| Special-Purpose | DM | Birth date collection using three date fields | 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. |
| Special-Purpose | DM | Birth date collection using three date fields | N/A | 4 | BRTHDD | Birth Day | Day of birth of the subject, in an unambiguous date format (e.g., DD). | What is the subject's day of birth? | Birth Day | Char | R/C | Record the subject's day of birth (e.g., 01 or 31). | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/A | Day 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-Purpose | DM | Birth date collection using three date fields | N/A | 5 | BRTHMO | Birth Month | Month of birth of the subject, in an unambiguous date format (e.g., MMM). | What is the subject's month of birth? | Birth Month | Char | R/C | Record the subject's month of birth [e.g., (in local language short month format) (JAN-DEC) or (ENE-DIE) or (JAN-DEZ), etc.]. | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/A | Month 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-Purpose | DM | Birth date collection using three date fields | N/A | 6 | BRTHYY | Birth Year | The year of birth of the subject, in an unambiguous date format (e.g., YYYY). | What is the subject's year of birth? | Birth Year | Char | R/C | Record the subject's year of birth (e.g., YYYY, a four-digit year). | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/A | Year 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-Purpose | DM | Birth date collection using three date fields | N/A | 7 | BRTHTIM | Birth Time | The time of birth of the subject, in an unambiguous time format (e.g., hh:mm). | What is the subject's time of birth? | Birth Time | Char | O | Record the time of birth (as completely as possible). | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/A | The 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-Purpose | DM | Birth date collection using three date fields | N/A | 8 | AGE | Age | The age of the subject, expressed in AGEU. | What is the subject's age? | Age | Num | O | Record age of the subject. | AGE | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | If 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-Purpose | DM | Birth date collection using three date fields | N/A | 9 | AGEU | Age Units | Units of time routinely used to express the age of a person. | What is the age unit used? | Age Unit | Char | O | Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.). | AGEU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (AGEU) | N/A | If 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-Purpose | DM | Birth date collection using three date fields | N/A | 10 | DMDAT | Demographics Collection Date | The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What is the date of collection? | Collection Date | Char | R/C | Record the date of collection using this format (DD-MON-YYYY). | Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-247 |
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| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-254 |
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| DMDTC | 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 DMDTC in ISO 8601 format. | N/A | N/A | The date of collection may be determined from the date of visit; if so, a separate date field is not needed. |
| Special-Purpose | DM | Birth date collection using three date fields | N/A | 11 | SEX | Sex | Sex of the subject, | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-718 |
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as determined by the investigator.. | What is the sex of the subject? | Sex | Char | R/C | Record the appropriate sex (e.g., F (female), M (male). | SEX | Maps directly to the tabulation variable listed in the Tabulation Target column. | (SEX) | N/A | Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment. | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-716a genotypic assessment. |
| Special-Purpose | DM | Birth date collection using three date fields | N/A | 12 | ETHNIC | Ethnicity | A 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? | Ethnicity | Char | O | Study participants should self-report ethnicity, with ethnicity being asked about before race. | ETHNIC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (ETHNIC) | N/A | When 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-Purpose | DM | Birth date collection using three date fields | N/A | 13 | CETHNIC | Collected Ethnicity | A 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? | Ethnicity | Char | O | Study participants should self-report ethnicity, with ethnicity being asked about before race. | SUPPDM.QVAL | This 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-Purpose | DM | Birth date collection using three date fields | N/A | 14 | RACE | Race | An 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.) | Race | Char | R/C | Study participants should self-report race, with race being asked about after ethnicity.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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keyTOBA-719 | | RACE | Maps 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 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-Purpose | DM | Birth date collection using three date fields | N/A | 15 | CRACE | Collected Race | An 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.) | Race | Char | R/C | Study 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.QVAL | This 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-Purpose | DM | Birth date collection using three date fields | N/A | 16 | RACEOTH | Race Other | A 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 Race | Char | O | If 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.QVAL | This 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/A | N/A | When 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-Purpose | DM | Birth date collection using a single date field | 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 in the database or populated during tabulation dataset creation. |
| Special-Purpose | DM | Birth date collection using a single date field | 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. |
| Special-Purpose | DM | Birth date collection using a single date field | 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. |
| Special-Purpose | DM | Birth date collection using a single date field | N/A | 4 | BRTHDAT | Birth Date | A 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 Date | Char | R/C | Record the date of birth to the level of precision known (e.g., day/month/year, year, month/year) in this format (DD-MON-YYYY). | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/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-Purpose | DM | Birth date collection using a single date field | N/A | 5 | BRTHTIM| Jira |
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| server | Issue Tracker (JIRA) |
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serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45 | | key | TOBA-249 |
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| Birth Time | The time of birth of the subject, in an unambiguous time format (e.g., hh:mm). | What is the subject's time of birth? | Birth Time | Char | O | Record the time of birth (as completely as possible). | BRTHDTC | 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 BRTHDTC in ISO 8601 format. | N/A | N/A | The 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-Purpose | DM | Birth date collection using a single date field | N/A | 6 | AGE | Age | The age of the subject, expressed in AGEU. | What is the subject's age? | Age | Num | O | Record age of the subject. | AGE | Maps directly to the tabulation variable listed in the Tabulation Target column. | N/A | N/A | If 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-Purpose | DM | Birth date collection using a single date field | N/A | 7 | AGEU | Age Units | Units of time that are routinely used to express the age of a person | What is the age unit used? | Age Unit | Char | O | Record the appropriate age unit (e.g., YEARS, MONTHS, WEEKS, etc.). | AGEU | Maps directly to the tabulation variable listed in the Tabulation Target column. | (AGEU) | N/A | If 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-Purpose | DM | Birth date collection using a single date field | N/A | 8 | DMDAT | Demographics Collection Date | The date of collection, represented in an unambiguous date format (e.g., DD-MON-YYYY). | What is the date of collection? | Collection Date | Char | R/C | Record the date of collection using this format (DD-MON-YYYY). | DMDTC | 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 DMDTC in ISO 8601 format. | N/A | N/A | The date of collection may be determined from the date of visit; if so, a separate date field is not needed. |
| Special-Purpose | DM | Birth date collection using a single date field | N/A | 9 | SEX | Sex | Sex of the subject, as determined by the investigator. | What is the sex of the subject? | Sex | Char | R/C | Record the appropriate sex (e.g., F (female), M (male). | SEX | Maps directly to the tabulation variable listed in the Tabulation Target column. | (SEX) | N/A | Collect the subject's sex or gender, as reported by the investigator. This is a phenotypic assessment and not a genotypic assessment. |
| Special-Purpose | DM | Birth date collection using a single date field | N/A | 10 | ETHNIC | Ethnicity | A 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? | Ethnicity | Char | O | Study participants should self-report ethnicity, with ethnicity being asked about before race. | ETHNIC | Maps directly to the tabulation variable listed in the Tabulation Target column. | (ETHNIC) | N/A | When 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-Purpose | DM | Birth date collection using a single date field | N/A | 11 | CETHNIC | Collected Ethnicity | A 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? | Ethnicity | Char | O | Study participants should self-report ethnicity, with ethnicity being asked about before race. | SUPPDM.QVAL | This 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-Purpose | DM | Birth date collection using a single date field | N/A | 12 | RACE | Race | An 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.) | Race | Char | R/C | Study participants should self-report race, with race being asked about after ethnicity. | RACE | Maps 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-Purpose | DM | Birth date collection using a single date field | N/A | 13 | CRACE | Collected Race | An 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.) | Race | Char | R/C | Study 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.QVAL | This 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-Purpose | DM | Birth date collection using a single date field | N/A | 14 | RACEOTH | Race Other | A 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 Race | Char | O | If 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.QVAL | This 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/A | N/A | When 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. |