When integrating an IRT (IWR/IVR) system with an EDC platform, avoid collecting CRF data in the IRT. Optimal goals for deploying an IRT are to screen subjects (i.e., assign a Subject ID), to randomize subjects to a treatment group, and to assign drug to subjects during the trial. We recommend our clients follow a ‘must have’ approach for data collected in the IRT and subsequently pushed to the EDC – in most cases, limiting the data transferred to the Subject ID, Visit ID, and IP assigned. We’ve found that it’s best to resist the temptation to use an IRT system as a ‘quick way’ to get to other data that will also be captured in the EDC system – for example, inclusion/exclusion data should ideally live only in the EDC database. Duplication in the IRT causes the IRT and EDC to require reconciliation to ensure data in the two systems are consistent and to resolve any discrepancies. The time and effort of a reconciliation can be eliminated, or at least reduced, by minimizing the amount of duplicate data in the two systems.
And another tip: In the EDC system, assign ‘read only’ status to any data field that receives input from the IRT system. This will ensure that any changes made to that data (example, correcting a data entry error for a subject’s date of birth) must be corrected first in the IRT, then the IRT “pushes” the new date to the EDC as an update. This approach to data changes helps to avoid the need for data reconciliation at the end of the study.
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