View period list
A period is a study phase in which the subjects are grouped and randomized. When the subject phases are configured in the Study Designer application and published to the EDC application, each phase intended for randomization generates a new period in IWRS.
Important
The IWRS system automatically initializes periods for a study based on the quantity and order of Randomized nodes configured in Study Designer.
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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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In the Period List table that appears, view the periods of your study and their details as explained in the following table.
Figure 1. Period list
Column
Details
Period Name
Represents the period name and an active link to period configuration (period factors, cohorts, and scrambled randomization).
Period Sequence
Represents the sequence number of the period in a study.
Scramble the Randomization Numbers
Represents if the scrambled randomization is applied to subject numbers (Yes) or not (No).
Description
Represents a meaningful description of the period, if any.
You have viewed the list of your study periods. You can now proceed with the period configuration.
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.
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.