Which of the following would the sponsor need to do FIRST to set up an...

The first step in establishing a robust quality management system (QMS) is to identify critical processes and data during protocol development. This step ensures that quality objectives are clear and that monitoring and quality control efforts are focused on the most significant aspects of the study. By understanding critical data points and processes early, the sponsor can design a more effective QMS to manage risks.

GCP guidelines emphasize identifying critical data and processes at the earliest stages to develop a risk-based quality management approach.

"Identification of critical data and processes at the protocol development stage is essential for designing an effective quality management system."

Objectives:

Establish quality oversight from the start.

Implement a risk-based monitoring approach.