NIH | National Cancer Institute | NCI Wiki  

Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

  2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

  3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

  4. On the Scientific Data menu, under Interventional Trial Design, click Design Details. The Interventional Trial Design Details page appears.

    HTML Comment
    hiddentrue

    Screenshot TBD.


  5. On Interventional Trial Design Details page, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    Trial Details

    Instruction

    Study Type*

    Select Interventional. (Selected by default)

    Info

    If you select Non-Interventional, the page will display the fields associated with non-interventional trials and you may lose any data you may have entered already.

    Expanded Access?

    Include Page
    Trial Design Expanded Access field - Include 20170406
    Trial Design Expanded Access field - Include 20170406

    Anchor
    primarypurposeinterventional
    primarypurposeinterventional
    Primary Purpose*

    1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions

    2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.

    Info

    The text field is displayed only after you have selected Other.

    Secondary Purpose

    1. Select one of the following reasons for conducting the trial.

    Include Page
    Secondary Purpose Values - Include v4.4
    Secondary Purpose Values - Include v4.4

    2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.

    Pragmatic Trial

    1. Trial Details - Pragmatic Trial

    2. Instruction - Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pragmatic trial.

    Trial Phase*

    Select the current phase of the trial. For valid values, refer to Trial Phase Value Definitions.

    Is this a Pilot?Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.

    Interventional Study Model*

    Select one of the following main study designs.

    Include Page
    Intervention Model Values - Include 20170406
    Intervention Model Values - Include 20170406

    Model DescriptionProvide any available details about the Interventional Study Model.

    Number of Arms*

    Anchor
    numberofarms
    numberofarms

    Type the number of treatment groups in the trial.

    Note
    titleImportant

    The number of arms you enter in this field must coincide with the number of trial arms you recorded or will record on the Arms page (see Abstracting Arms). Do not leave this field blank or enter "0" (zero).

    Masking*

    Select all of the roles that are masked, or select No Masking:
    • Participant: The participant (or subject) is unaware of the intervention assignment.
    • Investigator: The investigator is unaware of the intervention assignment.
    • Care Provider: The care provider (or caregiver) is unaware of the intervention assignment.
    • Outcomes Assessor: The outcomes assessor is unaware of the intervention assignment.
    • No Masking: All people involved in the study know the identity of the intervention assignment.
    Masking Description Provide any available details about the masked parties.

    Allocation*

    Select the means by which participants are assigned to an intervention group.

    Include Page
    Allocation Values - Include v4.4
    Allocation Values - Include v4.4

    Target Enrollment*

    If the Enrollment Type is Anticipated, enter the target number of subjects in the study.

    Tip
    • Do not give a range.
    • Add the number of subjects in each arm or phase together to get the total enrollment if needed.
    • Use the informed consent document to help you to identify the target enrollment if the protocol is unclear.

    Final Enrollment for ClinicalTrials.gov 

    If the Enrollment Type is Actual, but the final enrollment has not been recorded or the value was corrected for the Results Reporting, you can enter the final number of subjects accrued.

    Info

    The system records a count of 0 if you do not enter a Final Enrollment accrual count, and the number of subjects accrued to date is 0.

    AccrualsThe system enters the number of accruals recorded to date in the CTRP automatically. You can not change this number.
  6. Click Save.