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Configure period

The configuration of a period is a complex process that can be logically divided into the following parts:

  • Period factor: to define the screening conditions (factors) that influence the randomization process.

  • Cohorts: to define the cohorts of subjects that are further assigned to different arms of a clinical trial according to the randomization scheme.

  • Scrambled randomization: to mix up all randomization numbers for all the subjects in all the cohorts within a period to prevent unexpected unbinding.

    Important

    The scrambled randomization is only available for multiperiod studies.

To view the period configurator

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. On the page that opens, in the left pane, select the Period subtab.

  3. In the Period List table that appears, locate the period of your interest. Then in the Period Name column, select the value to open the period configurator.

    Accessing period configurator
    Figure 1. Accessing period configurator

    Tip

    You can also change the period for configuration from the period configurator directly. For this, expand the dropdown menu on the top left and select the period of your interest.

    Viewing period configurator
    Figure 2. Viewing period configurator

As a result, you can start configuring period scrambled numbers, factors, and cohorts per your needs.

In this section:

In IWRS, a period is a study phase in which the subjects are grouped and randomized. The Period functionality in the application is the main unit of the configuration of the subject randomization process.

The period configuration is a complex process of defining the screening conditions (factors) and cohorts of subjects that are further assigned to different arms according to the randomization scheme.

A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

A participant who is enrolled in a clinical trial and assigned to the site.

A group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

A scheme (plan) according to which subjects enrolled in a study are randomized and receive their treatment.