Fact Sheet
Protocol Deviations
Streamline Protocol Deviation Management and Review Context: Addressing deviations from clinical trial protocols is an extremely important process that is necessary to ensure data integrity and participant safety. However, managing protocol deviation data can pose significant challenges for sponsors as it is collected across a number of sources — CROs, CRAs, CTMS systems, etc. — and at an increasingly rapid pace. With different data conventions and structures for each data source, it has become difficult for sponsors to combine and then surface protocol deviation data for efficient review prior to regulatory submission. Oftentimes, sponsors must leverage disparate trackers with inconsistent standards to manage protocol deviation data, leading to inefficient, manual processes that increase room for error. Protocol Deviations: Protocol Deviations, part of the elluminate Clinical Data Cloud®, centralizes protocol deviation data across all sources, providing sponsors a single platform to manage the increasing volume and variety of protocol deviation data generated in today’s complex trials. Taking a platform approach streamlines protocol deviation management processes, enabling users to ingest, standardize, manage and identify trends in protocol deviations — across all data sources — from a central location. In turn, discrepancies between data sources are eliminated, resulting in real-time insights that support greater efficiency, enhanced oversight, and ensured trial compliance.