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Abstracting Non-Interventional Trial Design

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Info
titleCheck out the trial before you begin abstraction

Before you begin abstracting or validating any trial, be sure you check it out first. Otherwise you will not be able to modify any trial data.

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Abstracting

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Non-Interventional Trial Design

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Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

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Abstracting

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Non-Interventional Trial Design -

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In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

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Select Non-Interventional. (Selected by default)

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Select one of the following trial types:

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Primary Purpose*

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1. Select the primary reason for conducting the trial. The following list provides valid values.

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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.

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

Trial Phase*

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1. Select the current phase of the trial. The following list provides valid values.

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The Pilot Trial? drop-down list is displayed only after you have selected N/A.

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

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

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

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

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Select the DNA retention indicator from one of the following:

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Target Enrollment*

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Type 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.

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Abstracting Outcomes

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You can search for, and select, interventions from a stored list of active intervention terms extracted from NCIt and link them to a trial. NCIt is an online database developed and maintained by the National Cancer Institute Enterprise Vocabulary Services. You can find more detailed information about NCIt at http://ncit.nci.nih.gov/.

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