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.
Benefits: Key Features:
Greater Efficiency
Leverages existing capabilities embedded within elluminate to rapidly ingest and map protocol deviation data to one common structure, minimizing manual data entry and reducing the potential for human error.
Enhanced Quality
A centralized location for all protocol deviation data eliminates data silos, reducing data discrepancies, and standardized Protocol Deviation Assessment Plans (PDAPs) enable uniform reporting.
Ensured Compliance
Real-time analytics and reporting enable sponsors to address issues promptly and demonstrate oversight, ensuring trials remain compliant with regulatory standards.
Smarter Decisions
With a central, standardized view of protocol deviation data, patterns and trends are more easily identified, enabling faster, data-driven decision-making.
The Global Protocol Deviation Assessment Plan (Global PDAP)
Provides a central standard or guideline for organizing Protocol Deviations across all studies, streamlining the process of PD review and identifying trends to reduce the number of deviations within a clinical trial overall.
The Study Protocol Deviation Assessment Plan (Study PDAP)
Provides the standard or guidelines for organizing and managing PDs for a specific study. The Study PDAP can inherit standards from the Global PDAP to ensure consistency across studies, and have additional standards added that are unique to the study.
Interactive Dashboards
Protocol Deviation dashboards in Data Cental provide an overview of key protocol deviation metrics including deviation counts, importance ratio, top standard categories, review progress, and status counts. The dashboard also features an interactive list of all protocol deviations where they can be viewed and created, and then moved through the protocol deviation management workflow.
About Us
eClinical Solutions’ industry-leading data & analytics platform, elluminate®, and biometrics services experts help biopharma researchers at large, mid-size, and emerging life sciences organizations manage trial complexity in less time and with fewer resources. Clients get accurate and timely data insights for better decision-making — enabling them to reduce cycle times, improve productivity, easily scale, and develop tomorrow’s breakthroughs with today’s resources.
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