Yesterday, we started a series of posts on protocol deviations by looking at how they are handled in GCP and regulations. Today, we ask our favorite question: Why do we collect, classify, categorize, trend, track, and respond to protocol deviations?
The regulations imply the following reasons:
Note these three objectives are the responsibility of three different parties – investigators, clinical operations, and biostatistics. Compliance and reporting to IRBs require real-time collection and assessment, whereas analysis and reporting in the CSR are post-hoc activities. Each objective requires stakeholders to distinguish a different subset of protocol deviations: compliance is concerned with trends and serious breaches; reporting concerns “immediate hazards,” “unanticipated problems,” and “important” deviations; analysis looks at “major” deviations.
These competing objectives and their inherent requirements for categorization and classification can result in a complex process that attempt to serve too many purposes. In the next post, we’ll look at how protocol deviations are typically collected, and how we can adjust the process to better achieve all three objectives.