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  1. Select the study you want to work with by following instructions in Searching for and Selecting Your Trials, and clicking the corresponding NCI Trial Identifier link. The Search Study Subject page appears.
  2. Click Add New Study Subject.
    The Add Study Subject page appears. (Screenshot below displays Subject accrual)
    Add Study Subject page
     

  3. Enter the required demographic information in the text fields and drop-down lists. An asterisk (*) indicates a required field. 

  4. The following table describes the valid values and formats for each field.

    Anchor
    Accrual Data Elements for Complete Trials
    Accrual Data Elements for Complete Trials

    Accrual Data Elements for Complete Studies
    Descriptions and instructions for Study Subject and Partial Subject demographic data fields



    Required/Conditional
    Accrual Data ElementDefinitionSubjectPartial SubjectAccepted Values
    Study Subject IDEnter the unique Patient ID as per the lead organization or the study site where the subject is registered.RRAny numeric or alphanumeric value
    Study Subject Birth Date (MM/YYYY)Enter the subject's month and year of birth in the format MM/YYYY.R
    Accrual application format: MM/YYYY
    REST Services format: YYYY-MM-DD
    Batch Upload format: YYYYMM
    Study Subject GenderSelect the subject’s biological sex. If biological sex information is not available, select Unknown.R
    Male
    Female
    Unspecified
    Undifferentiated
    Unknown
    Study Subject Race

    Select one or more values for race. 

    To select multiple races, select one race, and then press and hold the CTRL/CMD key as you select the other(s).

    R

    American Indian or Alaska Native
    Asian
    Black or African American
    Native Hawaiian or Other Pacific Islander
    Not Reported
    Unknown
    White

    Study Subject EthnicitySelect a value for ethnicity.R
    Hispanic or Latino
    Not Hispanic or Latino
    Not Reported
    Unknown
    Study Subject CountrySelect the study subject's country of residence.R


    Study Subject Zip CodeEnter the study subject’s zip code. CC

    Required if the Study Subject Country is the US, US territories and outlying islands.

    Must be in a 5 digit or 9 digit (DDDDD-DDDD) format

    Registration DateEnter the date that the subject was registered on the study.RRAccrual application format: MM/DD/YYYY
    REST Services format: YYYY-MM-DD
    Batch Upload format: YYYYMMDD
    Disease (for ICD-O-3 Disease Codes)

    Click Look Up, and follow the instructions in Selecting Diseases for Study Subject Records.

    Note: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.

    R

    Partial Subject:

    Disease is not required.

    ICD-O-3: If Disease is reported, Site is also required.


    Study Subject:

    Disease Code is required for all studies. (Optional for DCP trials)

    ICD-O-3: Disease and Site are required.

    Site (for ICD-O-3 Disease Codes)

    Click Look Up, and follow the instructions in Selecting Sites for Study Subject Records Using ICD-O-3 Codes.

    Site Code information is available at:

    http://www.iacr.com.fr/index.php?option=com_content&view=category&layout=blog&id=100&Itemid=577

    Note: CTRP uses a hybrid model with the codes from IACR and the codes in NCI SEER that are not available in IACR.


    C

    Partial Subject:

    Site is not required.

    ICD-O-3: If Site is reported, Disease is also required.


    Study Subject:

    Site is required for all studies. (Optional for DCP trials)

    ICD-O-3: Site and Disease are required.

    Participating SiteSelect the appropriate site from the drop-down list.RR
    Study Subject method of paymentSelect the appropriate payment method.

    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

  5. Click Save.
    The study subject record appears in the List of Study Subjects.

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