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This section describes how to search for, add, update, and delete study subjects associated with Complete clinical trials. For information about Abbreviated trials, see Working With Abbreviated Trial Accruals .
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Adding Study Subjects
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| MultiExcerptName | subjectadd |
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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. |
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How to Add Study Subject Records
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Study Subject Information
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Instruction/Description
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Study Subject ID*
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Enter the unique Patient ID as per the lead organization or the study site where the subject is registered.
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Study Subject Birth Date*
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Enter the subject's month and year of birth in the format MM/YYYY .
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Study Subject Gender*
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Select the subject’s gender. If gender information is not available, select Unknown.
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Study Subject Race*
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Select one or more values for race.
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To select multiple races, select one race, and then press and hold the CTRL/CMD key as you select the other(s). |
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Study Subject Ethnicity*
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Select a value for ethnicity.
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Study Subject Country*
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Select the subject’s country of origin.
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Study Subject Zip Code
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Enter the subject’s Zip Code if known. This field is mandatory if the country of origin is United States.
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Enter the date that the subject was registered for the trial.
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Study Subject Method of Payment
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For United States study subjects only, select the appropriate payment method.
Site*
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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.
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Disease*
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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).
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Participating Site*
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Select the appropriate site from the drop-down list.
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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. |
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Searching for Diseases and Sites
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| MultiExcerptName | diseasesearch |
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You can search for diseases directly from the toolbar or while adding or entering study subject records. Refer to the instructions below.
- Searching for Diseases from the Toolbar
- Selecting Diseases for Study Subject Records
- Selecting Sites for Study Subject Records Using ICD-O-3 Codes
Searching for Diseases from the Toolbar
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| MultiExcerptName | diseasesearchmainmenu |
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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 Working with Complete Trial Accruals .
How to Search for Diseases from the Toolbar
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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.
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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. |
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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)
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Press Enter, or click Search.
The system searches for the disease/condition or site in the database, and returns a list of results.
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Selecting Diseases for Study Subject Records
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| MultiExcerptName | diseasesearchselect |
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How to Search for and Select Diseases
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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.
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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. |
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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)
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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.
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Selecting Sites for Study Subject Records Using ICD-O-3 Codes
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| MultiExcerptName | selectsite |
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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
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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.
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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. |
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Searching for Study Subjects
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| MultiExcerptName | subjectsearch |
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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
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Type or select your search criteria from one or more of the fields provided.
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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. |
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- 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
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Reviewing Study Subject Records
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| MultiExcerptName | subjectrecordreview |
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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
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