Your EDC system will house the bulk of your clinical data for the upcoming clinical trial but you're using an IRT for screening, randomization, and drug assignment. What's the most efficient, cost-effective way to accomplish two key study goals: to integrate certain data as needed (in a timely fashion), and to avoid time-wasting duplication and reconciliation requirements between systems?
In general terms, the most efficient approach to data integration is to transfer data in only one direction. Pushing data from the IRT to the EDC is a far better solution than pushing some data and pulling other data from the EDC into the IRT. In many scenarios, each direction incurs a separate charge; maintaining uni-directionality reduces costs. In addition, consistently moving data via the IRT's standard data transfer processes -- with expertise developed through multiple integrations with a wide variety of EDC platforms -- simplifies the startup challenges involved.
With Veracity Logic's system, for example, transaction-based data transfer has been honed to achieve very near real-time -- typically, by the time the user randomizes a subject and exits the IRT system, the data is available for use in the EDC.
Limiting directionality also eliminates duplication, which in turn eliminates the need for data reconciliation. Instead of a user having to screen a subject in the EDC and then either require the IRT to pull in the subject ID or require the user to re-enter it into the IRT (which would need reconciliation), users use the screening capabilities of the IRT to assign the subject ID, then the data is pushed to the EDC. When a screened subject qualifies for randomization, the IRT already has the subject ID. The subject can be randomized and the activity data (typically the visit date and kit assignment) is pushed to the EDC almost instantaneously. In most IRTs, including Veracity Logic's system, screening and randomization are part of the basic CORE system whether the functionality is utilized or not.
Finally, we work with our clients to define which data points actually need to be transferred between systems during the study and which can quite happily be transferred in bulk at study end or at preset points during the study. The IRT's inventory and shipping information, and drug assignment data by visit are readily available for ongoing viewing (and creating summary reports on demand) throughout the study, but can and should generally remain located only in the IRT until study end.
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