CDE Detailed Report

Prior TBI studies utilized the Employment Status data element for data capture

Choose one.

Text for all languages participant/subject speaks fluently. It may be easier to record the full name of the language and code the data later using the ISO 639-2 codes.

The language data should be coded using the ISO 639-2 codes prior to aggregation or sharing.

Choose all that apply

Choose only one country which the subject/participant currently lives. If the country code is not included on the form then code the data later using ISO 3166-1 alpha-2 codes. If ISO code does not exist, use Country of residence name CDE to write the country name.

Choose only one country which the subject/participant currently lives. If the country code is not included on the form, 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)

Category of race(s) or region(s) the parent, guardian, or caregiver most closely identifies with

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 subject's enrolled on an annual basis using the racial categories listed.

The indicator related to whether subject played sports in junior high school

Specify the reason for unemployment

Text for participant/subject's birth country. It may be easier to record the full name of the country and code the data later in Birth country ISO code using the ISO 3166-1 alpha-2 codes.

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)

The indicator related to which sports subject played in junior high school

Specify the reason for unemployment

Number of dependent children for a participant/subject

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.

Data Sharing Instructions: When date/time data are prepared for aggregation or sharing they should be converted to the format specified by ISO 8601, YYYY-MM-DDThh:mm:ss.

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.

Code (ISO 3166-1 alpha-2 code) for country where the participant/subject was born

The number of years subject played sport(s) in junior high school

The subject's age is typically recorded to the nearest full year completed, e.g., 11 years and 6 months should be recorded as 11 years. For subject's which are under 1 year old, use decimal points and use the following convention: record 1 month as 0.083 (1/12), 2 months as 0.166 (2/12), 3 months as 0.25 (3/12), 4 months as 0.333 (4/12), 5 months as 0.416 (5/12), 6 months as 0.5 (6/12), 7 months as 0.583 (7/12), 8 months as 0.666 (8/12), 9 months as 0.75 (9/12), 10 months as 0.833 (10/12), 11 months as 0.916 (11/12) and 12 months as 1 year.