Edit period
In IWRS, a period is a study phase in which the subjects are grouped and randomized.
The IWRS system automatically initializes periods for a study based on the quantity and order of Randomized nodes in the subject phase configuration of the Study Designer (SD) application. Thus, each randomization-related phase configured in SD becomes a period in your study in IWRS.
Even though you cannot manually create periods in IWRS, you can edit some period configurations, such as a name, description, or a scrambled randomization setting.
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In the IWRS application header, select the TREATMENT DESIGN tab.
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On the page that opens, from the left pane, select Period.
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On the Period List page, locate the period that you want to edit, and from the Action(s) column next to it, select Edit
.
Figure 1. Selecting to edit period
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In the Edit dialog that opens, update period details as explained in the following table.
Figure 2. Editing period
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Period Name*
Enter the period name.
Period Sequence*
Represents the sequence number of the period. The value is read-only and preconfigured in the SD application.
Description
Enter a description to depict the period's significance in a study.
Scramble the Randomization Numbers
In a multiperiod study, for a period that has no randomization schemes yet, turn the toggle on or off to enable or disable scrambling of randomization numbers before assigning them to subjects to enhance blinding security.
The toggle is disabled for studies with a single period and the periods that already have the generated randomization scheme.SAVE
Select
to save your changes.CANCEL
Select
to discard changes without saving.
Once saved, your changes are implemented. The edits you have made are recorded to the period operation history.
A process of assigning subjects to different cohorts based on the inclusion criteria.
A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.
A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.
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In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.
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 scheme (plan) according to which subjects enrolled in a study are randomized and receive their treatment.