Introduction to IWRS
IWRS stands for Interactive Web Response System and represents an eClinical application that provides unified and configurable subject randomization and trial supply management solutions.
The IWRS application gives you an opportunity to manage subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.
IWRS is highly integrated with two other eClinical applications—Study Designer (SD) and Electronic Data Capture (EDC).
In SD, data managers design CRFs (Case Report Forms) defining the future visits structure, forms (including the drug dispensing forms) that will be filled during subjects' visits, and items of those forms. All the visits have to be assigned to different arms to ensure that each group of subjects has its appropriate visits to sites.
Important
Depending on the SD configurations, subject data can be synchronized between EDC and IWRS to determine grouping, randomization, and drug dispensing processes, and the results of drug dispensing in IWRS can also be recorded in EDC as subject data.
When all the appropriate settings are completed in SD, the CRF is pushed to the EDC application that is intended for subject data capture. In EDC, the subject is enrolled in a study according to the CRF structure defined in SD.
As soon as the subject is enrolled into a study, the captured subject data is synchronized to the IWRS application where the grouping and randomization processes take place.
As a result, each subject is assigned to a cohort, an arm, and a random number. This data is transferred back to EDC as the subject's basic information.
The drug dispensation process is also managed in the IWRS application. When subjects receive drugs at visits to sites, the dispensing results (such as dispensing time, dispensing type, item numbers, and others) are recorded by the IWRS system and sent to the EDC application as values to the drug dispensing form designed in SD.