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Set condition for subject replacement in cohort

The randomized subjects included in the cohort can be replaced. When a subject is discontinued, the sponsor can replace the discontinued subject with a new subject. The new subject is assigned the same treatment design, moreover, the same arm of the discontinued subject is assigned to the new subject. This helps in making the treatment assignment balanced.

For instance, if one subject is no longer qualified to take part in a study and their participation is ceased, a new subject is enrolled and, in simple words, takes the place of the discontinued subject. Thus, the newly enrolled subject must be assigned to the same study group and receive the same treatment to maintain balance.

To make subject replacement possible, you need to set up a condition that, once met, enables the system to recognize that one subject qualifies to replace the discontinued one.

Important

This functionality is only available if the permuted block randomization method is selected for your cohort.

To set a condition for subject replacement in a cohort

  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

  4. In the period configurator, drill down the explorer menu and select the Cohort List subtab.

    Accessing cohort list
    Figure 2. Accessing cohort list

  5. From the list of cohorts, expand the one of your interest and select Subject Replacement replace_icon.png.

    Selecting subject replacement
    Figure 3. Selecting subject replacement

  6. On the Subject Replacement page that appears, in the Expression editor, set the condition against which the system validates if the subject qualifies for replacement. Only the subjects for whom all the conditions set in this expression are true become eligible for replacement.

    Important

    If you clear the expression and save, the system will allow you to replace the existing subjects without prior condition validation. For such an unconditional replacement setting, you can enable the review and approval procedure to introduce a tier of scrutiny.

    Viewing subject replacement
    Figure 4. Viewing subject replacement

  7. Select save_button_red.png to implement the changes.

Once saved, the replacement condition becomes active. Once the set condition is met the discontinued subject is replaced with the new one.

In this section:

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

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

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.