Getting Data Sooner With IRT

Case Studies

The Challenge:

A classic problem in the conduct of a clinical trial is how to motivate site personnel to enter their clinical data in a timely fashion. What can be done to enable project personnel to receive study data sooner?

The Solution:

The simple premise of "give some, get some" describes the success of IRT systems in breaking the traditional data log jam. Data from the IRT is typically received quickly, and early in advance of eCRFs. Why is that?

In a nutshell, IRTs specialize in processes that require the user to interact with the system in order to achieve their visit goals. Interacting with an IRT-- unlike much of the clinical database --is not an add-on activity to be trudged through when a study coordinator has time. Rather, it is an essential part of successful study conduct.

For example, obtaining Subject ID is one of the first goals of registering a new patient. In the best study designs, screening and/or randomization numbers (preferably one and the same) are assigned by the IRT, a reality which prompts users to enter the new subject into the system in real time fashion. Ditto for randomizing the subject to a treatment group, an act required to obtain the drug assignment for that subject. The same is true for all subsequent visits at which study drug is assigned.

Optimally, use of the IRT will be limited to visits at which the site needs to receive something -- either the next drug assignment or other interactive requirements like a dose-based-on-weight calculation needed before subject treatment  can proceed. In another instance, unscheduled drug resupply to compensate for kit loss or kit damage requires interaction with the IRT to provide an alternate unit.

Study Managers should keep in mind the simple principle of "give some, get some" in deciding whether or not to use -- and how best to use -- an IRT on their next clinical trial.

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