Accrual Data Elements for Complete Studies
Descriptions and instructions for Study Subject and Partial Subject demographic data fields
Required/Conditional | ||||
---|---|---|---|---|
Accrual Data Element | Definition | Subject | Partial Subject | Accepted Values |
Study Subject ID | Enter the unique Patient ID as per the lead organization or the study site where the subject is registered. | R | R | Any numeric or alphanumeric value |
Study Subject Birth Date (MM/YYYY) | Enter the subject's month and year of birth in the format MM/YYYY . | R | Accrual application format: MM/YYYY REST Services format: YYYY-MM-DD Batch Upload format: YYYYMM | |
Study Subject Gender | Select the subject’s biological sex. If biological sex information is not available, select Unknown. | R | Male Female Unspecified Undifferentiated Unknown | |
Study Subject Race | Select one or more values for race. To select multiple races, select one race, and then press and hold the CTRL/CMD key as you select the other(s). | R | American Indian or Alaska Native | |
Study Subject Ethnicity | Select a value for ethnicity. | R | Hispanic or Latino Not Hispanic or Latino Not Reported Unknown | |
Study Subject Country | Select the study subject's country of residence. | R | CTRP is using the International Standards Organization country codes | |
Study Subject Zip Code | Enter the study subject’s zip code. | C | C | Required if the Study Subject Country is the US, US territories and outlying islands. Must be in a 5 digit or 9 digit (DDDDD-DDDD) format |
Registration Date | Enter the date that the subject was registered on the study. | R | R | Accrual application format: MM/DD/YYYY REST Services format: YYYY-MM-DD Batch Upload format: YYYYMMDD |
Disease | Click Look Up, and follow the instructions in Selecting Diseases for Study Subject Records. Note: For ICD-O-3, CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR. | R | Partial Subject: Disease is not required. ICD-O-3: If Disease is reported, Site is also required.
Disease Code is required for all trial types. ICD-O-3: Disease and Site are required. | |
Site (for ICD-O-3 Disease Codes) | Click Look Up, and follow the instructions in Selecting Sites for Study Subject Records Using ICD-O-3 Codes. Site Code information is available at: http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577 Note: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR. | C | Partial Subject: Site is not required. ICD-O-3: If Site is reported, Disease is also required.
Site is required for all trial types. ICD-O-3: Site and Disease are required. | |
Participating Site | Select the appropriate site from the drop-down list. | R | R | |
Study Subject method of payment | Select the appropriate payment method. | Private Insurance |