Operational Disruption: Assuring Clinical Data Integrity

By Doug Shaw, Karen Travers, Ed Drower, and Hannah Yee

In a recent Speaker Series hosted by Halloran on "Operational Disruption: Assuring Clinical Data Integrity," our team delved into the complexities and critical factors involved in safeguarding data integrity, addressing both preventive and reactive measures.

Regulatory bodies, including Health Authorities like ICH, EMA, FDA, ISO, and MHRA, establish guidelines to ensure the safety, intended use, and quality processes of biopharma products and medical devices throughout their life cycle. Good Practice Quality Guidelines and Regulations (GxP) compliance is mandated by these authorities through country-specific regulations, emphasizing traceability, accountability, and data integrity. The focus of our discussion centered on the pivotal aspect of data integrity within this framework.

By examining industry trends, we found a significant prevalence of data integrity concerns, with approximately 50% of global product inspection observation forms and 79% of global drug warning letters citing such issues from 2014-2018. The escalating reliance on partner systems, Software as a Service (SaaS), and connected devices amplifies the challenge of maintaining data integrity across a diverse ecosystem of data sources.

The rise in outsourcing and unclear sponsor oversight responsibilities necessitates heightened due diligence, such as audits, for selected vendors. For sponsors involved in or planning clinical trials, three key takeaways emerge for protocol preparation and navigating disruptions mid-stream. These considerations become crucial in ensuring the integrity of clinical data in an evolving landscape marked by technological dependencies and external collaborations.