CDE Detailed Report

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)

Specify the reason for unemployment

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.

Number of dependent children for a participant/subject

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

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 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.