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Page History
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Abstracting Interventional Trial Design
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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. |
How to Abstract Interventional Trial Design Details
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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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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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Trial Details
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Instruction
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Select Interventional. (Selected by default)
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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. |
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Primary Purpose*
1. Select the primary reason for conducting the trial. The following list provides valid values.
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2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided.
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The text field is displayed only after you have selected Other. |
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1. Select one of the following reasons for conducting the trial.
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2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
Trial Phase*
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1. Select the current phase of the trial. The following list provides valid values.
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2. If the trial phase is N/A, indicate whether the trial is a pilot by selecting Yes or No from the Pilot Trial? drop-down list.
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The Pilot Trial? drop-down list is displayed only after you have selected N/A. |
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Intervention Model*
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Number of Arms*
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Type the number of treatment groups in the trial.
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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). |
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Masking*
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Masking Role(s)*
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- Subject
- Investigator
- Caregiver
- Outcomes Assessor
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Allocation*
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Study Classification
Select the type of primary outcome or endpoint that the trial is designed to evaluate.
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Target Enrollment*
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If the Enrollment Type is Anticipated, enter the target number of subjects in the study.
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If the Enrollment Type is Actual, but the final enrollment has not been recorded, you can enter the final number of subjects accrued.
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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. |
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Abstracting Non-Interventional Trial Design
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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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