What is the goal of ICH E6 in implementing a risk-based approach to quality management?

What is the goal of ICH E6 in implementing a risk-based approach to quality management?

• A. To increase the number of audits performed
• B. To determine which study risks may be omitted from continual monitoring
• C. To decrease investigator involvement
• D. To simplify documentation requirements

Answer: (B)

The goal of ICH E6 in implementing a risk-based approach to quality management is to focus on identifying and mitigating risks that could impact the quality and integrity of clinical trial data and participant safety. By prioritizing risks, sponsors and investigators can allocate resources more effectively and ensure that critical aspects of a clinical trial are continuously monitored while allowing for more flexibility in areas that are deemed lower risk. This risk-based approach does not mean eliminating oversight; instead, it prioritizes monitoring efforts based on the assessment of potential risks to ensure that critical data and study processes are managed appropriately. This targeted approach helps to enhance the quality and efficiency of clinical trials while ensuring compliance with regulatory requirements. The other options do not align with the core objective of a risk-based management approach as seen in ICH E6. Increasing the number of audits may lead to unnecessary resource expenditure, while decreasing investigator involvement runs counter to the need for oversight and engagement in trial management. Simplifying documentation requirements does not capture the central focus on risk assessment and management inherent to the ICH E6 guidelines.

The goal of ICH E6 in implementing a risk-based approach to quality management is to focus on identifying and mitigating risks that could impact the quality and integrity of clinical trial data and participant safety. By prioritizing risks, sponsors and investigators can allocate resources more effectively and ensure that critical aspects of a clinical trial are continuously monitored while allowing for more flexibility in areas that are deemed lower risk.

This risk-based approach does not mean eliminating oversight; instead, it prioritizes monitoring efforts based on the assessment of potential risks to ensure that critical data and study processes are managed appropriately. This targeted approach helps to enhance the quality and efficiency of clinical trials while ensuring compliance with regulatory requirements.

The other options do not align with the core objective of a risk-based management approach as seen in ICH E6. Increasing the number of audits may lead to unnecessary resource expenditure, while decreasing investigator involvement runs counter to the need for oversight and engagement in trial management. Simplifying documentation requirements does not capture the central focus on risk assessment and management inherent to the ICH E6 guidelines.