How to Abstract Non-Interventional Trial Design

  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 Non-interventional Trial Design, click Design Details. The Non-Interventional Trial Design - Design Details page appears.

    Screenshot TBD.

  5. In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

    FieldDescription/Instruction
    Study Type*

    Select Non-Interventional. (Selected by default)

    Expanded Access?

    Non-Interventional Trial Type*

    Select one of the following trial types:

    Primary Purpose*

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

    2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either Observational or Ancillary -Correlative , in the text field.

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

    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.
    Study Model*

    1. Select the primary strategy for subject identification and follow-up. The following list provides valid values.


    2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided.

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

    Time Perspective*

    1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values.


    2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided.

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

    Biospecimen Retention

    Select the DNA retention indicator from one of the following:

    • None Retained - No samples retained
    • Samples With DNA - Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood)
    • Samples Without DNA - Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)
    Biospecimen DescriptionSpecify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).
    Number of Groups/Cohorts*

    		Enter the number of treatment groups/cohorts in the trial. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two.

    Target Enrollment*

    Type the target number of subjects in the study.

    • 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.
  6. Click Save.