CDE Detailed Report

Disease: Multiple Sclerosis
Sub-Domain: Demographics
CRF: Demographics

Displaying 1 - 9 of 9
CDE ID CDE Name Variable Name Definition Short Description Additional Notes (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
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

Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

C19052 State or province of residence other text StateProvinceResidenceOTH The free-text field related to 'State or province of residence text' specifying other text. Abbreviation for the state or province where the participant/subject currently lives The free-text field related to 'State or province of residence text' specifying other text. Abbreviation for the state or province where the participant/subject currently lives Other, specify Alphanumeric

Enter the abbreviation for the state or province. The 2-letter postal abbreviation should be used for all U.S. states. Data element and all values comply with Clinical Data Update System (CDUS) v3.0 Release 2.

The string of characters used to identify the five-digit Zone Improvement Plan (ZIP) code and the four-digit extension code (if available) that represents the geographic segment that is a subunit of the ZIPcode, assigned by the U.S. Postal Service to a geographic location to facilitate mail delivery; or the postal zone specific to the country, other than the U.S., where the mail is delivered. Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Demographics Demographics Participant Characteristics 4000

Free-Form Entry

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

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. 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.).

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
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
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 reported 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). 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. Gender is the socially constructed identity of sex. Gender is equated with phenotypic sex. Gender may differ from the sex of an individual determined genetically. Self-reported gender of the participant/subject. Gender is the socially constructed identity of sex. Gender Female;Male;Unknown;Unspecified;Not reported Female;Male;Unknown;Undifferentiated/Indeterminant/Intersex;Not reported 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
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 US;CA;GB;MX;AU;Other, specify USA (US);Canada (CA);United Kingdom (GB);Mexico (MX);Australia (AU);Other, specify Alphanumeric

Choose only one country which the subject/participant currently lives. If the country code is not included on the form and therefore the country is written-in under 'Other, specify' then code the data later using ISO 3166-1 alpha-2 codes.

ISO 3166-1 alpha-2 codes (http://www.iso.org/iso/iso_3166_code_lists) Adult;Pediatric Supplemental 3.00 2013-07-11 15:03:49.2 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

C10677 ZIP partial code ZIPPartialCode First three digits of the zip code where the participant/subject currently lives. First three digits of the zip code where the participant/subject currently lives. Zip/Postal Code Alphanumeric

Protected health information (PHI), under the Health Insurance Portability and Accountability Act (HIPAA), does allow collection of the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people. For CDUS reporting, the last four digits of the complete nine-digit Zip code should not be submitted to assure patient confidentiality. If the initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. In addition, this is usually an optional field. Therefore, if not provided, also enter 000.

No references available Adult;Pediatric Supplemental 3.00 2013-07-16 14:01:43.01 Demographics Demographics Participant Characteristics 255

Free-Form Entry

C16204 State or province of residence text StateProvinceResidenceTxt Abbreviation for the state or province where the participant/subject currently lives Abbreviation for the state or province where the participant/subject currently lives State / Province AL;AK;AZ;AR;CA;CO;CT;DC;DE;FL;GA;HI;ID;IL;IN;IA;KS;KY;LA;ME;MD;MA;MI;MN;MS;MO;MT;NE;NV;NH;NJ;NM;NY;NC;ND;OH;OK;OR;PA;RI;SC;SD;TN;TX;UT;VT;VA;WA;WV;WI;WY;Other, specify AL;AK;AZ;AR;CA;CO;CT;DC;DE;FL;GA;HI;ID;IL;IN;IA;KS;KY;LA;ME;MD;MA;MI;MN;MS;MO;MT;NE;NV;NH;NJ;NM;NY;NC;ND;OH;OK;OR;PA;RI;SC;SD;TN;TX;UT;VT;VA;WA;WV;WI;WY;Other, specify Alphanumeric

Enter the abbreviation for the state or province. The 2-letter postal abbreviation should be used for all U.S. states. Data element and all values comply with Clinical Data Update System (CDUS) v3.0 Release 2.

The string of characters used to identify the five-digit Zone Improvement Plan (ZIP) code and the four-digit extension code (if available) that represents the geographic segment that is a subunit of the ZIPcode, assigned by the U.S. Postal Service to a geographic location to facilitate mail delivery; or the postal zone specific to the country, other than the U.S., where the mail is delivered. Adult;Pediatric Supplemental 3.00 2013-06-11 00:00:00.0 Demographics Demographics Participant Characteristics

Single Pre-Defined Value Selected

CSV