Question: In planning for a large - scale cardiovascular health study, the research team decides to implement a quality by design ( QbD ) approach to
In planning for a largescale cardiovascular health study, the research team decides to implement a quality by design QbD approach to ensure high levels of data integrity and participant safety. This approach necessitates identifying and managing potential risks from the outset and incorporating quality management practices throughout the study lifecycle. As the team prepares to develop their quality management plan QMP they first need to address a critical preliminary step to align with QbD principles.
Which of the following actions is most essential for the research team to undertake before finalizing the study design and developing the QMP in accordance with quality by design QbD principles?
Option A
Selecting the most advanced statistical analysis techniques to ensure that the study's data analysis phase is as robust and comprehensive as possible.
Option B
Training all study personnel on the use of the study's electronic data capture EDC system to ensure accurate data entry and minimize userrelated errors.
Option C
Conducting a detailed costbenefit analysis of various data collection tools to identify the most costeffective options for the study.
Option D
Developing an Integrated Quality Risk Assessment Plan to systematically identify, assess, and manage potential risks related to subject safety and data quality.
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