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:
- Improve the PD management process
- Reduce the PD processing burden on sites
- Reduce protocol deviation reporting time
- 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 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
The Protocol Deviations Initiative is developing a Management Toolkit consisting of tools and insights for consideration. Come back soon for updates on our resources.
Common Protocol Template
The Common Protocol Template Initiative is working with industry stakeholders and regulators to create a model clinical trial protocol template containing a common structure and model language to improve accuracy in data recordation and speed study start up.
Risk Based Monitoring
TransCelerate’s Risk Based Monitoring initiative seeks to develop a model approach for risk-based monitoring of clinical trials, with the goal to both enhance patient safety and ensure the quality of clinical data.
Value of Safety Information Data Sources
The Value of Safety Information Data Sources Initiative will seek to identify sources of safety information for a single high value valid cases and develop a proposed method for aggregate reporting of lower value cases.