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Subject Accrual Data Elements for Complete Trials

Subject Accrual Data Elements Table with CTRP-accepted Values

Subject Accrual Data Element NameMandatory=M; Optional=O
Conditional = C
DefinitionCTRP Accepted ValuesInformation Model Class / Diagram MappingComments/Conditions
Study IdentifierMUnique identifier assigned to the studyNCI, CTEP, or DCP IdentifierStudy Protocol / assignedIdentfier--
Study Subject Identifier MUnique 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 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 codePatient / postalAddressMandatory 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 CodesPatient / postalAddressMandatory if not U.S.
Patient’s Date of BirthMThe month and year on which the person was born

YYYYMM

Patient / birthDate

Year 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
  • Male
  • Female
  • Unspecified
  • Unknown
Patient / sexCodeIdentification 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
  • Hispanic or Latino
  • Not Hispanic or Latino
  • Not Reported
  • Unknown
Patient / ethnicGroupCode--
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
  • Private Insurance
  • Medicare
  • Medicare and Private Insurance
  • Medicaid
  • Medicaid and Medicare
  • Military or Veterans Sponsored, NOS
  • Military Sponsored (Including CHAMPUS & TRICARE)
  • Veterans Sponsored
  • Self-Pay (No Insurance)
  • No Means of Payment (No Insurance)
  • Managed Care
  • State Supplemental Health Insurance
  • Other
  • Unknown
StudySubject / paymentMethodCode--
Subject Registration Date MDate the subject was registered to the studyYYYYMMDDPerformedSubjectMilestone / registrationDate--
Registering Group CodeO

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

CTRP Person/Organization ID (PO ID)

Study Site / identifier--
Subject Disease CodeM

Code that identifies a disease

  • CTEP Simplified Disease Code (SDC) terms
  • ICD 9 CM codes
For SDC Disease Code:
StudySubject / diease_identifier

For ICD9 Disease Code:
StudySubject / icd9diease_identifier

Disease code is mandatory for all trials except those managed by DCP PIO.

Cancer specific ICD9 CM disease codes in the range 140 to 239. Information about these disease codes is available at http://www.icd9data.com/2012/Volume1/140-239/default.htm

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RaceMText for reporting information about race based on the Office of Management and Budget (OMB) categories
  • American Indian or Alaska Native
  • Asian
  • Black or African American
  • Native Hawaiian or Other Pacific Islander
  • Not Reported
  • Unknown
  • White
Patient / raceCode--
Change CodeOAdditions or changes since the last report
  • 1
  • 2
  • NULL
AccrualCollections / changeCode

1 or NULL = changes in the file;  CTRP will process and save the submission

2 = no changes in the file:  CTRP will not process the file, but will save the submission

 

Subject Accrual Data Elements Table with CDUS-accepted Values

Subject 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 ICD9 CM disease codes in the range 140 to 239. Information about these disease codes is available at http://www.icd9data.com/2012/Volume1/140-239/default.htm

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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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