Period
In IWRS, a period is a study phase in which the subjects are grouped and randomized.
The Period subtab is the main unit of the randomization process in IWRS that aims at the configuration of subject randomization. Also, once all the period-related configurations are made in IWRS, the system is ready to perform randomization in EDC.
Important
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 application.
This part of the user guide explains how to:
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.
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.
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.