NIH | National Cancer Institute | NCI Wiki  

Error rendering macro 'rw-search'

null

Versions Compared

Old Version 3

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

compared with

New Version 4

changes.mady.by.user Frost, Ruth (NIH/NCI) [C]

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Comment: Moved content to child pages.

...

Column
width40%
Panel
titleTopic Links

Table of Contents
maxLevel4
minLevel2

...

This page tree describes how to search for, add, update, and delete study subjects associated with Complete clinical trials.

Page Tree
rootWorking with Complete Trial Accruals
startDepth2

For information about Abbreviated trials, see Working With Abbreviated Trial Accruals.

Info

When working with study subject records, use either ICD-9, ICD-O-3, ICD-10, or SDC code terminology, regardless of your submission method (via the web application or batch upload); do not use different

codes for the same record.
Anchor
51575157
Anchor
61366136

Adding Study Subjects

Multiexcerpt
MultiExcerptNamesubjectadd

Return to top of page

Searching for Diseases from the Toolbar

...

MultiExcerptNamediseasesearchmainmenu

...

You can search for diseases by name or code directly from the toolbar. For instructions for selecting diseases, for example, when you add or edit a study subject record, see Selecting Diseases for Study Subject Records.

How to Search for Diseases from the Toolbar

...

In the Disease Name field, type part or all of the disease/condition or site being studied, or, in the Disease Code field, enter part or all of the disease or site code.

Tip
titleSearch tips

Enter as many letters of the disease/condition name as possible to reduce the number of search results. The system adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (%) between characters of the string as necessary.

...

From the Disease Code System drop-down list, select one of the following:

  • ICD-9 (International Classification of Diseases, 9th Revision)

  • ICD-10 (International Classification of Diseases, 10th Revision)

  • ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition)

  • SDC (CTEP's Simplified Disease Classification)

...

Press Enter, or click Search.
The system searches for the disease/condition or site in the database, and returns a list of results.

Search Diseases page with list of disease search resultsImage Removed

Return to top of page

Selecting Diseases for Study Subject Records

You can add one or more study subject accrual records for any trial to which you have been granted access.

Multiexcerpt
MultiExcerptNamediseasesearchselect
Anchor
subjectaddsubjectadd
Footnote

If your organization currently submits subject accrual information for studies to CTEP or DCP via the CDUS system, continue to report subject accrual information via CDUS. The NCI will manage the transfer of subject accrual data for CDUS trials internally. Otherwise, submit your organization's subject accrual data to CTRP.

See Requesting Permission to Submit Accrual Data .
Study subject records include demographic data as well as the disease name.

How to Add Study Subject Records

  • Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and clicking the corresponding NCI Trial Identifier link.
    The Search Study Subject page appears.
    Search Study Subject pageImage Removed
    • Click Add New Study Subject.
    The Add Study Subject page appears.
    Add Study Subject pageImage Removed
      Anchor58645864Enter the appropriate demographic information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field. For a list of valid values and formats for each field, see Accrual Data Elements for Complete Trials .
    Descriptions and instructions for study subject demographic data fields

    Study Subject Information

    Instruction/Description

    Study Subject ID*

    Enter the unique Patient ID as per the lead organization or the study site where the subject is registered.

    Study Subject Birth Date*

    Enter the subject's month and year of birth in the format MM/YYYY .

    Study Subject Gender*

    Select the subject’s gender. If gender information is not available, select Unknown.

    Study Subject Race*

    Select one or more values for race.

    Tip

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

    Study Subject Ethnicity*

    Select a value for ethnicity.

    Study Subject Country*

    Select the subject’s country of origin.

    Study Subject Zip Code

    Enter the subject’s Zip Code if known. This field is mandatory if the country of origin is United States.

    Registration Date*

    Enter the date that the subject was registered for the trial.

    Study Subject Method of Payment

    For United States study subjects only, select the appropriate payment method.

    Site*

    Anchor61366136

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

    Mandatory for ICD-O-3 trials unless you record a CD-O-3 Disease Code. Optionally, record both Site and Disease codes.
    Site codes are available at http://training.seer.cancer.gov/head-neck/abstract-code-stage/codes.html.

    Disease*

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

    Mandatory for ICD-9 and SDC trials; and for ICD-O-3 trials unless you record a CD-O-3 Site Code.

    Use Histology

    codes

    when C codes are not available (for example, for Multiple Myeloma, NHL, Leukemia).

    Participating Site*

    Select the appropriate site from the drop-down list.

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

    You can submit accrual data to the NCI CTEP's Clinical Data Update System (CDUS) on a quarterly basis (i.e., December 31, March 31, June 30) up to 30 days following the end of the quarter.

    For Complete trials, lead organizations report all subjects accrued for the trial (both in the lead organization and in all participating sites). For Abbreviated trials, each participating site reports the number of its own accruals (accrual count) only. 

    ---

    Footnotes Display

    Return to top of page

    Searching for Diseases and Sites

    ...

    MultiExcerptNamediseasesearch

    ...

    You can search for diseases directly from the toolbar or while adding or entering study subject records. Refer to the instructions below.

    The procedure for searching for diseases while adding or entering study subject records is the same as that for searching for them using the Disease Search menu. The difference is that in addition to searching for diseases, you can select them for association with the study subject record.

    How to Search for and Select Diseases

  • Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and clicking the corresponding NCI Trial Identifier link.
  • At the bottom of the Search Study Subject section, click Add New Study Subject.
    The Add Study Subject page appears.
    Add Study Subject pageImage Removed
  • To assign a disease to the study subject, next to the Disease field, click Look Up.
    The Search Diseases window appears.
    Search Diseases pageImage Removed
    • In the Disease Name field, type part or all of the disease/condition or site being studied, or, in the Disease Code field, enter part or all of the disease or site code

    .

    Anchor
    diseasesearchselectdiseasesearchselect

    Tip
    titleSearch tips

    Type as many letters of the disease/condition or site name as possible to reduce the number of search results. The system adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (%) between characters of the string as necessary.

    6136 Anchor

    Anchor

    6136

    5157
    5157

    Include PageDisease Codes for Non-diseases - Include v4.4Disease Codes for Non-diseases - Include v4.4

  • From the Disease Code System drop-down list, select one of the following:

    • ICD-9 (International Classification of Diseases, 9th Revision)

    • ICD-10 (International Classification of Diseases, 10th Revision)

    • ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition)

    • SDC (CTEP's Simplified Disease Classification)

    Info

    If the trial has at least one existing study subject record, the Disease Code System displays only the code system associated with the existing record(s). This ensures that all subjects in the study share the same terminology.

    • Press Enter, or click Search.
    The system searches for the disease/condition in the database, and returns a list of results. 

      Search Diseases page with list of disease search resultsImage Removed
  • Navigate to the disease/condition being studied, and click Select. See Working With Accrual Tables and Search Results .
    The system populates the Disease field for you.

    • Return to top of page

    Selecting Sites for Study Subject Records Using ICD-O-3 Codes

    ...

    • Study Subject ID
    • Date on which the subject was registered at a given participating site
    • The Participating Site where this subject is registered
    • Date/Time when this record was updated in CTRP

    ...

    Return to top of page

    Reviewing Study Subject Records

    ...

    MultiExcerptNamesubjectrecordreview

    ...

    CTRP Accrual site enables you to review the collection of non PII (Personally Identifiable Information) study subject data associated with a particular non-industrial trial registered with the CTRP.

    How to Review Study Subject Records

    ...

    Return to top of page 

    ...

    For trials that use ICD-O-3 trials, select a site to associate with a study subject. The site code is optional if you associate(ed) a disease code with the subject.

    How to Search for Sites

  • Select the trial you want to work with by following instructions in Selecting Listed Trials in Accrual or Searching for Trials in Accrual , and clicking the corresponding NCI Trial Identifier link.
  • At the bottom of the Search Study Subject section, click Add New Study Subject.
    The Add Study Subject page appears.
    • To assign a site to the study subject, next to the Site field, click Look Up.
    The Search Sites window appears.
    Search Sites pageImage Removed

    In the Site Name field, type part or all of the site being studied. The Site Code System, ICD-O-3 (International Classification of Diseases for Oncology, 3rd Edition) is preselected for you.

    title

    Multiexcerpt
    MultiExcerptNameselectsite
    Anchor
    selectsiteselectsite
    Tip

    Search tips

    Type as many letters of the site name as possible to reduce the number of search results. The system adds wildcards on both sides of the search string (the series of letters you type) for you implicitly. You can type wildcard symbols (%) between characters of the string as necessary.

    Anchor
    6136
    6136

    Press Enter, or click Search.
    The system searches for the site in the database and returns a list of results.
    Search Sites page with list of anatomical site search resultsImage Removed
  • Navigate to the site being studied, and click Select. See Working with Accrual Tables and Search Results .
    The system populates the Site field for you.

    • Return to top of page

    Searching for Study Subjects

    ...

    MultiExcerptNamesubjectsearch

    ...

    You can search for a particular study subject record using any combination of the following three criteria:

    • Study Subject ID
    • Participating Site
    • Birth Date

    You must select a trial before you can search for study subjects. For instructions, see Searching for and Selecting Your Trials .

    How to Search for Study Subjects

    ...

    Type or select your search criteria from one or more of the fields provided.

    Tip
    titleYou can list all study subjects

    You can search for a trial by one or more criteria, or you can list all subjects associated with trials to which you have been granted access by leaving all of the search criteria fields blank.