View period operation history
In IWRS, a period is a study phase in which the subjects are grouped and randomized.
The IWRS system automatically initializes study periods based on the Study Designer (SD) configurations: each randomization-related subject phase configured in SD becomes a period in your study in IWRS.
All the configurations that you perform with the period in IWRS, such as editing period details, adding period factors, and so on are recorded in the system and traceable via the period operation history.
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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, locate the period for which you want to view the operation history. Then from the Action(s) column next to it, select Operation History
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Figure 1. Selecting to view operation history
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In the Operation History dialog that opens, view the details of all operations performed with the period.
Figure 2. Viewing period operation history
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Select
to close the dialog.
You have viewed the history of operations with the period. Once the dialog closes, you return to the Period List page.
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 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 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.