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 Accrual Data Elements table with CDUS-Accepted values for Complete trials

Accrual Data Element NameMandatory=M; Optional=O
Conditional = C
DefinitionCDUS Accepted ValuesComments/Conditions
Study IdentifierMUnique identifier assigned to the studyCTEP Identifier --
Study Subject Identifier MUnique identifier (numeric or alphanumeric) assigned to subjects in a study

Any numeric or alphanumeric value assigned to a study subject

--
ZIP Code CString 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 codeMandatory if U.S.
Country of ResidenceCName of a country from which a person or their biological family had previous residence or past ancestors.2-letter ISO Country CodesMandatory if not U.S.
Patient’s Date of BirthMThe month and year on which the person was bornYYYYMMYear and Month are mandatory
Gender of a PersonMText designations that identify gender. Gender is described as the assemblage of properties that distinguish people on the basis of their societal roles
  • 1 = Male
  • 2 = Female
  • 9 = Unknown
Identification of gender is based upon self-report and may come from a form, questionnaire, interview, etc.
EthnicityMText for reporting information about ethnicity based on the Office of Management and Budget (OMB) categories
  • 1 = Hispanic or Latino
  • 2 = Not Hispanic or Latino
  • 8 = Not Reported
  • 9 = Unknown
--
Payment MethodOTerm 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
  • 1 = Private Insurance
  • 2 = Medicare
  • 3 = Medicare and Private Insurance
  • 4 = Medicaid
  • 5 = Medicaid and Medicare
  • 6 = Military or Veterans Sponsored, Not Otherwise Specified (NOS)
  • 6A = Military Sponsored (including CHAMPUS or TRICARE)
  • 6B = Veterans Sponsored
  • 7 = Self pay (no insurance)
  • 8 = No means of payment (no insurance)
  • 98 = Other
  • 99 = Unknown
--
Subject Registration Date MDate the subject was registered to the studyYYYYMMDD--
Registering Group CodeO

Unique CTEP Group code assigned to the group that originally registered the patient for the study

 --

--

Study Site IdentifierMUnique identifier (PO ID) assigned to the institution accruing the patient to the study

CTEP Site  ID

--
Subject Disease CodeM

Code that identifies a disease

  • CTEP Simplified Disease Code (SDC) terms
  • ICD-9-CM codes

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

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RaceMText for reporting information about race based on the Office of Management and Budget (OMB) categories
  • 01 = White
  • 03 = Black or African American
  • 04 = Native Hawaiian or Other Pacific Islander
  • 05 = Asian
  • 06 = American Indian or Alaska Native
  • 98 = Not Reported
  • 99 = Unknown
--
Change CodeOAdditions or changes since the last report----
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