Accrual Data Elements table with CTRP-Accepted values for Complete trials
Accrual Data Element Name | Mandatory=M; Optional=O Conditional = C | Definition | CTRP Accepted Values | Information Model Class / Diagram Mapping | Comments/Conditions |
Study Identifier | M | Unique identifier assigned to the study | NCI, CTEP, or DCP Identifier | Study Protocol / assignedIdentfier | -- |
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 | Study Subject / identifier | -- |
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 | Patient / postalAddress | Mandatory if U.S. |
Country of Residence | C | Name of a country from which a person or their biological family had previous residence or past ancestors. | 2-letter ISO Country Codes | Patient / postalAddress | Mandatory if not U.S. |
Patient’s Date of Birth | M | The month and year on which the person was born | YYYYMM | Patient / birthDate | Year and Month are mandatory. |
Gender 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 |
| Patient / sexCode | Identification of gender is based upon self-report and may come from a form, questionnaire, interview, etc. Genders in batch files do not have to correspond to the gender indicated as a trial eligibility criterion. |
Ethnicity | M | Text for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories |
| Patient / ethnicGroupCode | -- |
Payment Method | O | Term for an entity, organization, government, corporation, health plan sponsor, or any other financial agent who pays a healthcare provider for the healthcare service rendered to a person or reimburses the cost of the healthcare service |
| StudySubject / paymentMethodCode | Payment Method Codes in batch files are not case-sensitive. |
Subject Registration Date | M | Date the subject was registered to the study | YYYYMMDD | PerformedSubjectMilestone / registrationDate | -- |
Registering Group Code | O | Unique CTEP Group code assigned to the group that originally registered the patient for the study | -- | StudySubject / registrationGroupId | For trials with Group participation, provide CTEP Group Code, if available |
Study Site Identifier | M | Unique identifier (PO ID) assigned to the institution accruing the patient to the study | CTRP Person/Organization ID (PO ID) | Study Site / identifier | -- |
Subject Disease Code
| M | Code that identifies a disease |
| For SDC Disease Code: StudySubject / diease_identifier For ICD-9 Disease Code: StudySubject / icd9diease_identifier | 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 For trials using ICD-O-3 terminology, use this position for Site and/or Histology Codes. When using both Site and Histology codes, separate them by a semicolon ( ; ). Site codes are available at http://training.seer.cancer.gov/head-neck/abstract-code-stage/codes.html. Use Histology codes when C codes are not available (for example, for Multiple Myeloma, NHL, Leukemia). For uploading CDUS batch files, see https://wiki.nci.nih.gov/display/CTRPdoc/Disease+Codes+for+Non-diseases+-+Include+v4.4 |
Race | M | Text for reporting information about race based on the Office of Management and Budget (OMB) categories |
| Patient / raceCode | Multiple races in batch files are permissible even if "Not Reported" or "Unknown" is indicated. |
Change Code | O | Additions or changes since the last report |
| AccrualCollections / changeCode | 1 or NULL = changes in the file; the CTRP system processes and saves the submission 2 = If the trial's current accrual is 0, the CTRP system processes the file as a Code 1 change. If the trial's current accrual is greater than 0, the system saves the file but does not process it. |