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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/.

Additionally, Protocol Abstraction provides a structure for describing drug, radiation, and surgical procedure details. It generates a description from values you provide for such parameters as dose, target site, frequency of administration, etc.

Obsolete terms

Some intervention terms become obsolete over time. When you validate the trial, the system displays an error message if the abstraction contains an obsolete term. If this occurs, look up the intervention name and replace the obsolete term with the new one.

Trials can have multiple intervention records. Each record displays the following information about the intervention:

Intervention data definitions

Column Name

Definition

Name

Standard name used to refer to each intervention. For drugs, this is the generic name. For investigational new drugs that do not yet have a generic name, this may be the chemical name, company code, or serial number.

Other Names

Synonym or other name 1

Description

For drug interventions, a summary of the drug’s chemical nature and (potential) mechanism of action, and/or details such as dosage form, dosage, frequency, and duration.
For other interventions, a summary of the procedure or device that provides key details that distinguish it from similar interventions.

Tip

You can generate descriptions for drug, radiation, and surgical procedure interventions using Protocol Abstraction’s structured approach. To do so, see Generating Drug, Radiation, and Procedure/Surgery Descriptions.

Type

Mode of intervention, for example, drug or device.

  1. Alternate names you record appear in the TSR and XML documents.

Additionally, you can add, edit, reorder, and delete records.

Sorting intervention records

You can change the sort order (ascending/descending) of any column other than Edit and Delete by clicking the column name and selecting the up or down arrow that appears.

 

Interventions page

For instructions, refer to the following pages: