In clinical research, there are two major regulatory concerns: patient safety and data integrity.
While there are many possible reasons for regulators to conduct an inspection during a clinical trial, most of the time, it’s to verify these two things and to ensure that the research is being conducted according to the study protocol and GCP regulations.
This white paper, “FDA Inspections of Clinical Investigators: Are You Ready?,” offers the following tips:
- How to ensure safety of patients
- How to make sure documentation is complete
- How to establish and maintain an effective CQM