Survey results from sponsors, sites and IRBs confirmed protocol deviation (PD) management processes are complex, varied and broadly impacted by a wide range of definitions for identification and classification. These differences are associated with process inefficiencies across both sites and sponsors which can hinder rapid identification of important PDs.

In response, the Protocol Deviations Initiative is developing a toolkit to support clarity in definition and a holistic approach to the management of protocol deviations. Improved protocol deviation processes should ultimately lead to improved patient safety, reliability of study data, human subject’s protections and data quality and more rapid identification of protocol deviations.


Benefits for Patients:

  • Improved identification of important protocol deviations
  • Improved patient safety and human subject’s protection
  • Reduction in site burden, potentially improving a study participant’s clinical research experience

Benefits for Sponsors:

  • Reduced burden associated with the interpretation of “important” deviations across all levels of a sponsor’s organization
  • Increased consistency in protocol deviation planning, processing, analysis and reporting mechanisms
  • Focused and efficient risk-based management of protocol deviations which could directly impact patient safety, reliability of study data, human subject’s protections and/or data quality

Benefits for Sites:

  • Reduced burden in protocol deviation definitions and associated site processes for management, reducing confusion and increasing speed of identifying important violations
  • Reduction in overall burden potentially increasing time with patients/study participants

Benefits for Regulatory Authorities:

  • Potential decreased protocol deviations reporting “noise”
  • Potential increased focus on deviations associated with patient safety, reliability of study data, human subjects protections and/or data quality

Available Assets

The public comment period has now closed. Comments and feedback are currently being reviewed and a final toolkit will be available in Q3 2020.

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