Factor list management

In IWRS, a factor is a condition that influences subject randomization and drug dispensation. The factors can be age, gender, health condition, and so on.

The factors you create in the Factor List module are then used as cohort inclusion criteria or as a treatment-determining characteristic in the subject dispensing plan.

For example, the age factor assigned as cohort inclusion criteria determines to which cohort the subject is assigned upon randomization. Once the subject is valid for drug dispensation, their treatment plan can also be dictated by the range of specific factors, such as their health condition, gender, age, or the cohort to which they belong.

All the factors previously created in the IWRS application are displayed under the TREATMENT DESIGN > Factor module. You can learn more about the details available in Factor List in the following table.

Figure 1. Factor list table

Column	Details
Type	Represents the factor type and determines how the factor has been created: Manual The factor is created in the IWRS system manually by the user. System The factor can only be created in IWRS and mapped to Date or Numeric item in EDC. You can set a date or number range as the factor value. When the data is entered in EDC and pushed to IWRS, the system maps the factor value according to the range within which the data is located. For instance, the factor can be Age group: 0~18, 19~55, 56~70. If a user enters the age of 32 in EDC, the data is pushed to IWRS and mapped to 19~55. This type is mostly used when the randomization is stratified by age or birth year. Read Only The factor is created in IWRS and is intended to include a certain data variable into the subject's statistical information in the system. These factors are not considered for randomization; their purpose is strictly informative. For instance, you can add a read-only factor "C1D1 Date of Visit" that captures the date when the subject's first visit of the first treatment cycle took place. This data can now be set to be displayed in reports so that it is easy to locate and track. CRF Mapping The factor is generated automatically by the system once it has been configured in the SD application via the CRF Design functionality.
Visit	Represents the visit name of the mapped factor (only for factors of the CRF Mapping and Read Only types).
Form	Represents the form name of the mapped factor (only for factors of the CRF Mapping and Read Only types).
Factor	Represents the factor name, namely: The user-entered name of the factor (for factors of the Manual and Read Only types). The question of the mapped item from the SD application (for factors of the CRF Mapping type).
Treatment Factor Range	Represents the range when the factor must be set: Treatment-specific Factor The value of the factor is set per treatment and reflects its characteristics that may influence subject allocation to cohorts. For instance, the "Cohort dose" or "Background therapy" factors can be considered treatment-specific. Visit-specific Factor The value of the factor is set per visit and can be related to its timing or circumstances that affect subject allocation to cohorts. For instance, the "Screening Date of Visit" or "Baseline disease activity at C1D1" factors can be considered visit-specific. Subject-specific Factor The value of the factor is set per subject reflecting their characteristics that should be balanced across cohorts. For instance, the "Age" or "Sex" factors can be considered subject-specific.
Change Factor Value	Represents if it is allowed or restricted to changing the factor value for a subject: Yes The value of the subject-specific factor can still be adjusted after it has been set and utilized in a dispensation. No The value of the subject-specific factor cannot be modified once it has been set and utilized in a dispensation.
Display in Reports	Represents if it is enabled in the system to display the factor value in the subject list and randomization reports.
Name in Reports	Represents the name of the factor that is displayed in the subject list and randomization reports. This one can be different from the factor name, for instance, it can be shorter to keep your report naming concise.
Description	Represents a detailed description of the factor (only for factors of the Manual type).
Factor Value	Represents the value of the factor. For instance, for the "Date of Birth" factor, values are the ranges of dates: "2000-01-01 ~ 2004-01-01" and "1970-01-01 ~ 1999-12-31." `If there are multiple factor values configured, they are listed here divided by commas.`
Factor Text	Represents the text defined to depict the factor value. For instance, for the "Date of Birth" factor, where the values are the ranges of dates—"2000-01-01 ~ 2004-01-01" and "1970-01-01 ~ 1999-12-31"—the text depicts the age group to which the subjects of the respective birth date belong: "Young adult" and "Adult." `If there are multiple factor texts configured, they are listed here divided by commas.`

In this section of the user guide, you can learn how to manage your factor list using the following actions:

In this section:

Factor list management

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