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Set stratification factors for uploaded randomization scheme

Stratification factors are the variables that are used to divide a group of subjects into subgroups according to certain criteria. You can add stratified factors for a randomization scheme of the Manual Upload type.

To set stratification factors for the uploaded randomization scheme

  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.

    Selecting period to configure
    Figure 1. Selecting period to configure

  4. In the period configurator explorer tree, select Period Factor period_factor_icon.png.

  5. On the Factor List page that opens, from the workspace toolbar, select New Item image58.jpg.

    Selecting to add new factor
    Figure 2. Selecting to add new factor

  6. In the Add dialog that appears, define the stratified factor parameters as suggested in the following table.

    Adding stratified factor
    Figure 3. Adding stratified factor

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Factor*

    Select the stratified factor populated from the Period Factor table.

    Level*

    Indicate the level of strata. The system preferentially stratifies subjects with higher-level factors.

    Type

    Represents the type of selected factor as follows:

    • Manual: the factor created in IWRS, and its data is not synced from EDC.

    • CRF Mapping: the factor created in SD and pushed to IWRS automatically. Depending on the SD setting, the factor value can be entered in IWRS and pushed to EDC, or entered in EDC and pushed to IWRS.

    • System: the factor created in IWRS and mapped to Date or Numeric item in EDC. It can be a date or number range. 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.

    Visit

    Represents the name of visit at which the factor value is recorded to the system.

    Form

    Represents the name of the case report form (CRF) in which the factor value is recorded to the system.

    Description

    Represents the description of the factor value if any.

    Factor Value

    Represents the factor value as is, for instance, M for male gender factor.

    Factor Text

    Represents the descriptive text of the factor value, for instance, Male for M factor value.

    SAVE

    Select save_button_red.png to add your stratified factor.

    CANCEL

    Select cancel_button_white_blue.png to stop defining your stratified factor, close the dialog, and return to the factor list of the Period configurator. In such a case, no changes are saved.

Once strata and factors are added, you can map the strata with the uploaded randomization scheme.

In this section:

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

Get to know all the possibilities of the app with the comprehensive SD User Guide.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.