Responsibilities Within a RBM Plan
Risk Indicators and Thresholds
Technology Guidance
Data Integrity
Metrics
Pace of Adoption
Data Integrity
According to the World Health Organization’s Guidance on Good Data and Record Management Practices, data integrity is the degree to which a collection of data is complete, consistent and accurate throughout the data lifecycle. Collected data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices.
The effectiveness of Off-site or Centralized monitoring requires data to be entered in a timely manner and be remotely accessible. In other words, timely quality data is at the heart of a successful RBM strategy.
To facilitate RBM and generate Risk Indicators, data from multiple sources would need to be integrated into a common platform. Moreover, to enable data integration and include data from other data providers – such as CROs – as well as reflect ongoing changes to RBM strategies, the RBM plan should allow for a flexible data model.
What are some key capabilities that will support data integrity and
risk assessment success?
Additional information on technology capabilities can be found in the TransCelerate paper, “RBM Update – Technology Considerations Part 2.”
RBM solutions offer companies a level of data visibility that didn’t previously exist – an aggregated, organized view of data that can help trials reach their clinical endpoints fast and safely.