Conducting Independent Verification of Quality and Integrity of Data: Introducing CROScheck(TM)

There is an increasing need to use data visualization tools to guarantee the quality, accuracy and integrity of clinical trial data. This need is mainly driven by the changes in regulatory requirements that aim to reduce the risk to patients through better quality data.

The FDA guidance for industry and the EMA reflection paper encourages greater reliance on centralized monitoring practices. 100% SDV is not required or expected by the FDA. Also, 100% SDV is limited in its ability to provide insight to data trends across time, patients, and clinical sites.

The new GCP Guidelines ICH E6(R2) are in effect from 14 June 2017. The guidelines highlight that you can use a more comprehensive statistical approach to interrogate data. Even non-critical data can indicate problems at a site so a statistical approach that looks at the totality of the data is an important key risk indicator. The guidelines state that “a sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor”.

Centralized monitoring appears to be the most suitable approach to improve data quality and patient safety in a cost‐efficient manner. For some studies the number of site visits can be reduced which reduces travel and monitoring costs – important given that up to 70% of trial costs are attributed to monitoring.

CROS NT has developed CROScheckTM as a response to the need for better data visualization and analytics.

risk based monitoring centralized statistical monitoring

 

Processes

  • Risk Management Metrics: Plan, SOPs/templates
  • Centralized Monitoring: Plan SOPs/templates
  • Centralized Statistical Planning: Plan/SOPs/Forms

People

  • Centralized Monitors
  • Statistical Monitors
  • Clinical Project Managers trained in risk plan

Technology

  • Real time intuitive data visualization
  • Cross study analytics
  • Risk-Based Monitoring
  • Central Statistical Intelligence