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This section describes how to submit and update accruals for non-interventional trials. Participating sites enter accrual data at the summary level by default. The summary level consists of the accrual count per site only. However, if there are no accrual records for your trial in CTRP currently, you can enter demographic accrual information at the study subject, or patient level. Once a participating site has recorded accruals, you can no longer choose which level to use; you must enter subsequent accrual data at the same level.

Submitting Accruals at the Subject Level for Non-Interventional Trials

How to Submit Accruals at the Subject Level for Non-Interventional Trials

  1. Select the trial you want to work with by following instructions in Searching for and Selecting Your Trials. The Search Study Subject/List of Study Subjects page appears. If no accrual counts have been recorded for this trial previously, you can elect to submit your accrual data at the summary level instead of the subject level.
    Search Study Subject page
  2. Optionally, to record accrual counts at the summary level, click Switch to Summary Level Accrual, and follow the instructions in Submitting Accruals at the Summary Level for Non-Interventional Trials. Otherwise, continue with the next steps.
  3. Click Add New Study Subject. The Add Study Subject page appears.
    Add Study Subject page

  4. Enter the appropriate demographic information in the text fields and select items from 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, refer to 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 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.

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

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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Submitting Accruals at the Summary Level for Non-Interventional Trials

Each participating site can submit/update the number of patients accrued to date per trial.

How to Submit Accruals at the Summary Level for Non-Interventional Trials

  1. Locate the trial of interest by following the instructions in Searching for and Selecting Your Trials.

  2. Click the trial's NCI Trial Identifier. The Participating Site Subject Accrual Count page appears. If no accrual counts have been recorded for this trial previously, you can elect to submit your accrual data at the subject level instead of the summary level.

  3. Optionally, to record accrual counts at the subject level, click Switch to Subject Level Accrual, and follow the instructions in Submitting Accruals at the Subject Level for Non-Interventional Trials. Otherwise, continue with the next steps.
  4. In the Number of Subjects Enrolled field(s), enter the number of subjects currently enrolled in this study at your site.
  5. (Optional) In the Cut-Off Date field, specify the date from which the cumulative accrual count was calculated. If you do not specify a cut-off date, the system considers the accrual submission date to be the cut-off date.
  6. To clear all the entries, click Reset. Otherwise, be sure to c lick the Save icon for each site.
    A message at the top of the table indicates that the record has been updated successfully. Because you submitted accrual counts at the summary level, you must continue to record accruals at this level in the future.

 

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