You can add one or more study subject accrual records for any trial to which you have been granted access. ¹ 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

1. 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.
   
   
2. Click Add New Study Subject.
   The Add Study Subject page appears.
   
    
   
   

3. Enter 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. 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*	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 Working with Complete Trial Accruals . 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.

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

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1. 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. ↩

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

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

1. On the toolbar, click Disease Search.
   The Search Diseases window appears.
   
   

2. 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.

   Search 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.

   
   

3. 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)

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

   

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

1. 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.
2. At the bottom of the Search Study Subject section, click Add New Study Subject.
   The Add Study Subject page appears.
   
3. To assign a disease to the study subject, next to the Disease field, click Look Up.
   The Search Diseases window appears.
   
   

4. 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.

   Search 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.

   
   

5. 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)

   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.

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

   
    
   
   

7. 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.

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

1. 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.
2. At the bottom of the Search Study Subject section, click Add New Study Subject.
   The Add Study Subject page appears.
3. To assign a site to the study subject, next to the Site field, click Look Up.
   The Search Sites window appears.
   
   
   

4. 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.

   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.

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

6. 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.

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

1. 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. 
   
    
   
   

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

   You 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.

3. Click Search.
   Your search results are displayed in the List of Study Subjects section of the page. The list is sorted by Study Subject ID and includes the following information:
   
   • 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
   
   
4. To delete a study subject record, click the Delete icon (trash can).
5. To edit a study subject record, click the Edit icon (pencil), and follow the instructions in Adding Study Subjects .

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

1. 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 Accrual Submissions page displays any accrual records that may have been submitted previously.
   
2. Click the Study Subject ID of interest.
   The Study Subject page displays the study subject's demographic details recorded to date as well as information about the record itself. 
   
    
3. To return to the accrual record, click Back.
4. To change the study  subject record, click Edit, and follow the instructions in Adding Study Subjects .