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Page History
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| Accrual Data Element Name | Mandatory=M; Optional=O Conditional = C | Definition | CDUS Accepted Values | Comments/Conditions | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Identifier | M | Unique identifier assigned to the study | CTEP Identifier | -- | ||||||||
| Study Subject Identifier | M | Unique identifier (numeric or alphanumeric) assigned to subjects in a study | Any numeric or alphanumeric value assigned to a study subject | -- | ||||||||
| ZIP Code | C | String of characters used to identify the five-digit Zone Improvement Plan (ZIP) code that represents the geographic segment that is a subunit of the ZIP code, assigned by the U.S. Postal Service to a geographic location to facilitate mail delivery. | 5 digit numeric ZIP code | Mandatory if patient’s Country of Residence is U.S. | ||||||||
| Country of Residence | C | For non-U.S. residents only. This should be used when patient participation from foreign countries is involved. For patients from outside the U.S., enter the foreign country code. Leave blank if the patient is a U.S. resident. CTRP is using the International Standards Organization country codes. Note: Either Zip code (if U.S resident) or country code (if not U.S resident) is mandatory. | 2-letter ISO Country Codes | Mandatory if not U.S. | ||||||||
| Patient’s Date of Birth | M | The month and year on which the person was born | YYYYMM | Year and Month are mandatory | ||||||||
| Study Subject Sex of a Person | M | Text designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles |
| Identification of gender is based upon self-report and may come from a form, questionnaire, interview, etc. | ||||||||
| Ethnicity | M | Text for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories |
| -- | ||||||||
| Subject Registration Date | M | Date the subject was registered to the study | YYYYMMDD | -- | ||||||||
| Study Site Identifier | M | Unique identifier (PO ID) assigned to the institution accruing the patient to the study | CTEP Site ID | -- | ||||||||
| Subject Disease Code | M | Code that identifies a disease |
| Disease code is mandatory for all trials except those managed by DCP PIO. Cancer specific ICD-9-CM disease codes in the range 140 to 239. Information about these disease codes is available at http://www.icd9data.com
| ||||||||
| Race | M | Text for reporting information about race based on the Office of Management and Budget (OMB) categories |
| -- | ||||||||
| Change Code | O | Additions or changes since the last report | -- | -- |
