Accrual Data Element |
Definition | Required (R)/Conditional (C) | Accepted Values | |
Subject | Partial Subject | |||
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 Birthdate | Enter the subject's month and year of birth in the format MM/YYYY. Age is calculated by the difference between the Study Subject Registration Date and Study Subject Birthdate. The subject's age reported in CTRP cannot be greater than 120 years. | R |
| Accrual application format: MM/YYYY |
Study Subject Sex | Sex means a person’s classification as male or female based on biological distinctions. Select the subject’s biological sex. If biological sex information is not available, select Unknown. | R |
| Male |
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 |
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 | User Interface format: MM/DD/YYYY |
Study Subject Disease | Click Look Up, and follow the instructions in Selecting Diseases for Study Subject Records. 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. |
Study Subject Disease Site (ICD-O-3) | 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 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 |
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