IWRS has become more of a rule rather than an exception in the conduct of modern day clinical trials. It is rapidly replacing IVRS, and the application is becoming more and more sophisticated. In clinical trials that were conducted a few years ago IVRS was used in randomization of subjects to treatment groups, and in the management of medication kit assignment. In more complicated studies with multiple phases, and where certain criteria have to be met before the subjects can be randomized, the IWRS can be utilized to keep a record of the criteria and to automatically randomize the subjects if the criteria are met. IWRS can also be applied to dynamic and adaptive study designs such as optimizing dose-response trials. The discussion will revolve around such uses of IWRS and its role in conduct of studies with complicated randomization criteria, thereby improving the quality of clinical trials.

1)What factors are considered in determining what functionality is appropriate for IWRS? 2)What real-world experiences with IWRS can you share – what went right or wrong? 3)If IWRS is not built into the electronic data capture system, what integration concerns may arise? 4)Has IWRS been useful in facilitating adaptations to a study?