CDE Detailed Report

Disease: Cerebral Palsy
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 17 of 17
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 / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
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 Date of Birth 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.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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
C11136 Country of origin paternal name CntryOfOriginPaternalName Father's country or countries of origin Father's country or countries of origin Father's country of origin Alphanumeric

Country data should be coded using the ISO 3166-1 alpha-2 codes prior to aggregation or sharing.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C00015 Education year count EduYrCt Number of years of education completed (age 5 and beyond) Number of years of education completed (age 5 and beyond) Number of years of education Numeric Values

For years completed, after the age of 5, code the number of years attained (0-30 years), normed to someone moving full time at the usual pace, i.e. a year that was repeated counts as only 1 year and the usual single-year full-time load completed over several years counts as 1 year. Certificate and technical programs do NOT count no matter how specialized. The number of years of typical completion of the relevant program is counted. If the subject obtained their education outside the United States, ask about their educational system to estimate the correct coding - Internship, Residency, and Fellowship years are experiential training and do not count.

Adult;Pediatric Supplemental-Highly Recommended 3.00 2013-07-22 16:57:17.79 Demographics Demographics Participant Characteristics

Free-Form Entry

0 30 year 3134878
C18806 Country of residence other text CntryResdnceISOOTH The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. The free-text field related to 'Country of residence code' specifying other text. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Other, specify Alphanumeric Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

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. Response is obtained by report of the participant/subject or caretaker. If more detailed characterizations of ethnicity are collected to enhance data quality and consistency, it is recommended that they be "collapsible" up to the two categories for reportable ethnicity, as needed for reporting to FDA under its guidance. Other regulatory bodies may expect the reporting of ethnicity values which more appropriately reflect the population of their areas (e.g., Japanese ancestry for MHLW reporting to Japan). These may be collected as an extension to the suggested code list.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 defines the minimum standard of basic 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) Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2192217
C21121 Subject zip postal code number SubjectZipPostalCodeNumber The number of the subject/participant's zip/postal code. The number of the subject/participant's zip/postal code. Zip/Postal Code Numeric Values Adult;Pediatric Supplemental 1.00 2015-06-12 15:21:41.0 Demographics Demographics Participant Characteristics

Free-Form Entry

C00026 Language spoken Fluent text LangSpokeFluentTxt Text for each language that the participant/subject speaks fluently Text for each language that the participant/subject speaks fluently Other, specify Alphanumeric ISO 639-2 language codes (http://www.loc.gov/standards/iso639-2/php/code_list.php) Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C22586 Maternal birth date MaternalBirthDate Date (and time, if applicable and known) the mother of the participant/subject was born Date (and time, if applicable and known) the mother of the participant/subject was born Maternal date of birth 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.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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 Supplemental 1.00 2016-07-08 13:57:06.0 Demographics Demographics Participant Characteristics

Free-Form Entry

C00028 Language spoken fluent ISO code LangSpokeFluentISOCode Code (ISO 639-2)for each language that the participant/subject speaks fluently Code (ISO 639-2)for each language that the participant/subject speaks fluently Language(s) fully fluent English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic;Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi) English (eng);Spanish (spa);German (ger);Chinese (chi);French/Creole (cpf);Arabic (ara);Russian (rus);Italian (ita);Polish (pol);Other specify;American Sign Language (sgn);Chinese languages (Chi) Alphanumeric

Choose all that apply. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes.

ISO 639-2 language codes (http://www.loc.gov/standards/iso639-2/php/code_list.php) Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Demographics Demographics Participant Characteristics

Multiple Pre-Defined Values Selected

C22587 Paternal birth date PaternalBirthDate Date (and time, if applicable and known) the father of the participant/subject was born Date (and time, if applicable and known) the father of the participant/subject was born Paternal date of birth 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.). Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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 Supplemental 1.00 2016-07-08 13:57:06.0 Demographics Demographics Participant Characteristics

Free-Form Entry

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 categories. 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 that apply. Response is obtained by report of the participant/subject or caretaker. Collecting information on race may not be allowed in some countries for concerns related to discrimination. In other countries, however, these concerns are considered a reason for recording race in order to guarantee equal access to care. Investigators receiving funding from the US National Institutes of Health (NIH) are required to report the number of subjects enrolled on an annual basis using the racial categories listed.

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 basic 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) 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/subject.. Gender Alphanumeric

Choose one. Response is obtained by report of the participant/subject or caretaker.

The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15 (http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm) Adult;Pediatric Core 3.00 2013-08-28 16:08:00.453 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

2200604
C00313 Medical history condition SNOMED CT code MedclHistCondSNOMEDCTCode Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject Systematized Nomenclature Of Medicine Clinical Terms (SNOMED CT) code for medical condition/disease reported by the participant/subject SNOMED CT Code Alphanumeric

Code each of the medical history conditions using SNOMED CT

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics 255

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C00322 Medical history condition text MedclHistCondTxt Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Verbatim text for the medical condition/disease reported by the participant/subject or documented in the medical record as part of medical history Medical History Term Alphanumeric

Record one Medical History term per line. See the data dictionary for additional information on coding the condition using SNOMED CT

SNOMED CT Codes (http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html) Adult;Pediatric Core 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

2003874
C10675 Country of origin maternal name CntryofOriginMaternalName Mother's country or countries of origin Mother's country or countries of origin Mother's country of origin Alphanumeric

Country data should be coded using the ISO 3166-1 alpha-2 codes prior to aggregation or sharing.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Supplemental 3.00 2013-07-25 08:54:08.2 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C00005 Birth country name BirthCntryName Name for country where the participant/subject was born Name for country where the participant/subject was born Country of Birth Alphanumeric

Choose one. It may be easier to record the full name of the country and code the data later using the ISO 3166-1 alpha-2 codes.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Core 3.00 2013-07-24 21:00:23.88 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C10676 Country of residence code CntryResdnceISOCode Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Code (ISO 3166-1 alpha-2) for the country where the participant/subject currently lives. Country of residence US;CA;GB;MX;AU;Other, specify USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify Alphanumeric

Country data should be coded using the ISO 3166-1 alpha-2 codes prior to aggregation or sharing.

Adult;Pediatric Core 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

CSV