What does mean Risk-Based Quality Management

Risk-Based Quality Management (RBQM) is a systematic approach that emphasizes the identification, assessment, and management of risks throughout the clinical trial process to ensure data integrity and participant safety. The cornerstone of RBQM is a well-constructed protocol, as highlighted by the Clinical Trial Transformation Initiative (CTTI) in 2025. This protocol must articulate a clearly defined research question and establish scientifically robust outcomes, validated by all stakeholders, including investigative sites and patient representatives. Involving patient representatives in outcome definition not only facilitates recruitment but also enhances the acceptance and marketability of the investigational product or medical device.

This methodology aligns with the principles of quality by design, as defined in ICH-GCP E6 R3 and ICH E8.

Stakeholders, such as patient representatives and clinical sites, will scrutinize the protocol for operational feasibility and workload implications. Protocols that attempt to address too many objectives or collect non-essential data risk becoming overly complex, thereby increasing the burden on sites and patients. This complexity leads to greater demands in data collection, cleaning, and analysis, which can escalate both workload and study costs. Furthermore, excessive data collection heightens the risk of errors and missing data, potentially complicating the analysis. ICH-GCP E6 R2 and R3 underscore the necessity for concise protocols and streamlined data collection procedures. Principle 8 states: “Clinical trials should be described in a clear, concise, scientifically sound, and operationally feasible protocol.” Additionally, "8.3 The clinical trial protocol as well as the plans or documents for the protocol execution (e.g., statistical analysis plan, data management plan, monitoring plan) should be clear, concise and operationally feasible."

A critical aspect of RBQM is determining which data are essential. This requires conducting a risk assessment at the outset of protocol development. Such an assessment identifies the critical data and processes necessary to address the research question, distinguishing them from non-essential elements that may be eliminated or simplified. This risk-proportional approach ensures the protocol remains focused and manageable for all stakeholders.

The risk assessment process should be initiated during protocol development and maintained throughout the project lifecycle, ensuring continuous quality oversight and effective risk management.

Should you require a more detailed explanation or wish to discuss the implementation of RBQM within your organization, please feel free to reach out for further support.

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