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Select subject-specific factor

The subject-specific factor is a value or a piece of information that determines the drug dispensation for the subject. Factors like the subject's gender, date of birth, drug dosing, and so on are unlikely to change for the subject throughout the study. Based on the study protocol, the subject-specific factors can be defined and configured in IWRS.

Some subject-specific factors (for example, the dosing or cohort) can be assigned automatically upon randomization if the arm to which the subject is randomized has the specific associated factors. Nevertheless, you can also select the subject-specific factors manually.

To select the subject-specific factor

  1. In the IWRS application header, select the SUBJECT tab.

  2. From Subject List that opens, select the needed site and subject.

    Selecting site and subject
    Figure 1. Selecting site and subject

  3. Under the Subject Information tab, in the Subject-specific Factor block, select the subject-specific factor value from the dropdown list.

    Selecting subject-specific factor value
    Figure 2. Selecting subject-specific factor value

    Important

    Based on the subject-specific factors and visit dispensing configurations, the number of subject-specific factors and values for them may differ.

  4. From the workspace toolbar, select save_button_red.png.

Once saved, the selected subject-specific factor value is now updated for the subject. If needed, you can manually sync this value to EDC.

In this section:

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

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.