A3.1 Dealing with multiple data sources: fundamental aspects of data integration and reconciliation for high data quality

This presentation is part of a full breakout session. To add this presentation to your schedule you must add the full breakout session.

As the penetration of technology in the clinical trials space has become spectacular, the industry has also significantly increased the volume of data collected, the variability of data sources, as well as the number of vendors and systems used. This generates a rising complexity in clinical trials operational structures, that may put at risk not only the user experience but also the quality and the integrity of the clinical trials’ data. In the increasingly frequent case of a clinical trial encompassing several systems such as eCRF, eConsent, IRT/IxRS, eCOA, and even potentially wearable data collection, we must ask ourselves the question: how to maximize data entry without jeopardizing data quality? How to reconcile data from these multiple sources without putting at risk each clinical study milestone? How to anticipate and organize the data management activities so that the data reconciliation process does not become an endless nightmare? Through detailed examples, this presentation will describe specific data management practices and customized approaches that can be put in place to meet the evolving needs of data integration and data reconciliation from multiple data sources. The converging perspectives of data management and clinical experts will bring broad views that should offer the audience food for reflection on how strong coordination and expert data management activities will be key to support new generation clinical trials.