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Protocol Deviations

Rationale

Currently, clinical research sponsors and sites are struggling to interpret certain elements of the ICH E3 and the associated guidelines related to protocol deviations (PD).  This difficulty has led to potential reporting delays, questions related to the classification of “important” and “non-important” deviations, reduced intra-organizational consistency, and a potential overreporting of deviations which could directly impact reliability of study data, human subject’s protections, patient safety and/or data quality.

Based on input from investigational CROs and sites, as well as research sponsors themselves, the TransCelerate Protocol Deviations Initiative is seeking health authority feedback on a proposed Protocol Deviation Management Toolkit developed to:

  1. Improve the PD management process
  2. Reduce the PD processing burden on sites
  3. Reduce protocol deviation reporting time
  4. Promote the more rapid identification of important protocol deviations

An improved protocol deviation processes should ultimately lead to improved patient safety, reliability of study data, human subject’s protections and data quality.

Benefits

Benefits for Patients:

  • Potential decrease in protocol deviation reporting time
  • 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:

  • Decreased variability in protocol deviation definitions and associated site processes for management, reducing confusion and overall burden
  • Reduced reporting delays potentially increasing time with patients/study participants

Benefits for Regulatory Authorities:

  • Potential decreased PD 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 Protocol Deviations Initiative is developing a Management Toolkit consisting of tools and insights for consideration. Come back soon for updates on our resources.

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