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Subject Accrual Data Elements for Abbreviated Trials

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The tables in this section contain detailed information on each of the data elements included in the Batch Upload file. The first table provides values that are valid for the Batch Upload file. The CDUS Accepted Values in the second table are provided to show differences in values in case your system is already producing the CDUS file.


Use of CDUS Values

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Although you can use CDUS values, they are being phased out in the CTRP. It is best, therefore, to use the CTRP values listed in the table below.


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When you create a batch file, ensure that each data element conforms to the requirements.

  • List each data element in its appropriate position in a given row
  • Use the correct character cases (CAPITAL vs. lower case letters)
  • Use the correct character lengths (number of characters allowed in a single field)
  • If a comma is part of the value, enclose the field in double quotes. Otherwise the use of double quotes is optional.

Subject Accrual Data Elements Table with CTRP Accepted Values for Abbreviated Trials

 

 Accrual Data Elements table with CTRP-Accepted values for Complete trials
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 / 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.

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 / paymentMethodCodePayment Method Codes in batch files are not case-sensitive.
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 Code

   

M

Code that identifies a disease

  • CTEP Simplified Disease Code (SDC) terms
  • ICD-9-CM codes
  • ICD-O-3 codes
  • ICD-10
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

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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 the note below this table.

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 / raceCodeMultiple races in batch files are permissible even if "Not Reported" or "Unknown" is indicated.
Change CodeOAdditions or changes since the last report
  • 1
  • 2
  • NULL
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.

For Super Abstractors uploading CDUS Accrual batch files

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Use the following default disease codes when uploading a CDUS accrual batch file:

  • For patients missing the disease code
    • ICD-9: V100
    • SDC: 80000001
    • ICD-O-3
      • Site code: C998
      • Histology code: 7001
    • ICD-10: Z1000

Use the CTEP SDC "disease not specified code" 80000001 by default if the trial currently has NO existing patients, and all disease codes in the CDUS file are missing.

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Subject Accrual Data Elements Table with CDUS Accepted Values for Abbreviated Trials

 

 Accrual Data Elements table with CDUS-Accepted values
Accrual Data Element NameMandatory=M; Optional=O
Conditional = C
DefinitionCDUS Accepted Values
Study IdentifierMUnique identifier assigned to the studyCTEP Identifier
Study Site IdentifierMUnique identifier (PO ID) assigned to the institution accruing the patient to the studyCTEP Site  ID
Study Site Accrual CountMN/A--

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