CDE Detailed Report
Disease: Traumatic Brain Injury
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 9 of 9
Subdomain Name: Demographics
CRF: Demographics
Displaying 1 - 9 of 9
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C00021 | Ethnicity USA paternal category | EthnUSAPatrnlCat | Ethnicity the participant/subject's father most closely identifies with | Ethnicity the participant/subject's father most closely identifies with | Paternal ethnicity | Unknown;Not reported;Hispanic or Latino;Not Hispanic or Latino | Unknown;Not reported;A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino.";A person not meeting the definition for Hispanic or Latino. | Alphanumeric |
Choose only one that the participant/subject's father most closely identifies. |
Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2182266;3182162;2192217 | ||||||||
| C00022 | Ethnicity USA maternal category | EthnUSAMatrnlCat | Ethnicity the participant/subject's mother most closely identifies with | Ethnicity the participant/subject's mother most closely identifies with | Maternal ethnicity | Unknown;Not reported;Hispanic or Latino;Not Hispanic or Latino | Unknown;Not reported;A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino.";A person not meeting the definition for Hispanic or Latino. | Alphanumeric |
Choose only one that the participant/subject's mother most closely identifies. |
Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217;3182162 | ||||||||
| C00032 | Race USA paternal category | RaceUSAPatrnlCat | Race(s) the participant/subject's father most closely identifies with | Race(s) the participant/subject's father most closely identifies with | Paternal race | American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;White;Unknown;Not Reported | A person having origins in any of the original peoples of North and South America (including Central America) , and who maintains tribal affiliation or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.;A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" can be used in addition to "Black or African American.";A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.;Could not be determined or unsure;Not provided or unavailable | Alphanumeric |
Choose all those racial categories that the participant/subject's father most closely identifies with. |
Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182269;2192199, 3182197 | ||||||||
| C00033 | Race USA maternal category | RaceUSAMatrnlCat | Race(s) the participant/subject's mother most closely identifies with | Race(s) the participant/subject's mother most closely identifies with | Maternal race | American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;White;Unknown;Not Reported | A person having origins in any of the original peoples of North and South America (including Central America) , and who maintains tribal affiliation or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.;A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" can be used in addition to "Black or African American.";A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.;Could not be determined or unsure;Not provided or unavailable | Alphanumeric |
Choose all those racial categories that the participant/subject's mother most closely identifies with. |
Pediatric | Supplemental | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
3182197;2192199 | ||||||||
| C00020 | Ethnicity USA category | EthnUSACat | Category of ethnicity the participant/subject most closely identifies with | Category of ethnicity the participant/subject most closely identifies with | Ethnicity | Hispanic or Latino;Not Hispanic or Latino;Unknown;Not reported;Other, specify | A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term "Spanish origin" can also be used in addition to "Hispanic or Latino.";A person not meeting the definition for Hispanic or Latino.;Could not be determined or unsure;Not reported;Other, specify | Alphanumeric |
Choose one |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. | Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2192217 | |||||||
| C00030 | Race USA category | RaceUSACat | The patient's self declared racial origination, independent of ethnic origination, using OMB approved categories | The patient's self declared racial origination, independent of ethnic origination, using OMB approved categori | Race category | American Indian or Alaska Native;Asian;Black or African-American;Native Hawaiian or Other Pacific Islander;White;Unknown;Not Reported | A person having origins in any of the original peoples of North and South America (including Central America) , and who maintains tribal affiliation or community attachment.;A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.;A person having origins in any of the black racial groups of Africa. Terms such as "Haitian" can be used in addition to "Black or African American.";A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.;A person having origins in any of the original peoples of Europe, the Middle East, or North Africa.;Could not be determined or unsure;Not provided or unavailable | Alphanumeric |
Choose all that apply. |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 defines the minimum standard of Core racial and ethnic categories. (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Collection of Race and Ethnicity Data in Clinical Trials (FDA, September 2005 - http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm) Jorde LB and Wooding SP. Genetic variation, classification and "race". Nature Genetics. 2004;36(11):S28-S33. Bhopal R and Donaldson L. White, European, Western, Caucasian, or What? Inappropriate labeling in Research on Race, Ethnicity, and Health. Amer J of Publ Health. 1998;88:1303-1307. | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Multiple Pre-Defined Values Selected |
2192199 | |||||||
| C00035 | Gender type | GenderTyp | Self-reported gender of the participant/subject | Self-reported gender of the participant/subjec | Gender | Alphanumeric |
Choose one |
The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget (OMB) Directive No. 15 - http://grants.nih.gov/grants/funding/women_min/women_min.htm Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. Mushkudiani et al J Neurotrauma 2007;24:329-37. Do women fare worse: a meta-analysis of gender differences in traumatic brain injury outcome. Farace et al, J Neurosurg 2000;93:539-545. | Adult;Pediatric | Core | 3.00 | 2013-08-28 16:08:00.453 | Demographics | Demographics | Participant Characteristics |
Single Pre-Defined Value Selected |
2200604 | |||||||||
| C18385 | Birth time | BrthTm | Time the subject was born | Time the subject was born | Birth time | Alphanumeric |
These elements may be included if relevant to the study. For additional details like permissible values, see the data dictionary associated with this CRF. |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Demographics | Demographics | Participant Characteristics | 255 |
Free-Form Entry |
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| C00007 | Birth date | BirthDate | Date (and time, if applicable and known) the participant/subject was born | Date (and time, if applicable and known) the participant/subject was born | Birth date | Date or Date & Time |
Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.). |
ISO 8601 - http://www.iso.org/iso/iso_catalogue.htm Management and prognosis of severe traumatic brain injury: Age. J Neurotrauma. 2000;17:573-581.; Mushkudiani NA, Engel DC, Steyerberg EW, et al. Prognostic value of demographic characteristics in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):259-69. Pediatric-specific reference(s): Anderson V, Catroppa C, Morse S, Haritou F, Rosenfeld J (2005) Functional plasticity or vulnerability after early brain injury. Pediatrics 116:1374-1382 | Adult;Pediatric | Core | 3.00 | 2013-07-25 08:54:08.2 | Demographics | Demographics | Participant Characteristics |
Free-Form Entry |
793 |
