In the realm of clinical research, two functions often work together to complement each other to create an additive impact on the overall quality and integrity of a clinical trial. The two functions are clinical monitoring and auditing. But how do these work hand-in-hand, and how are they different?
Many professionals working in the clinical research arena may not appreciate or understand the roles and differences between clinical research auditing and monitoring, two distinctly different functions. Or if they do, they may not understand that the two functions can have an additive rather than redundant impact on quality.
IMARC’s whitepaper dives into these questions and takes an in-depth look at:
- The differences between Auditing versus Monitoring
- If I have great monitors, why should I audit?
- How monitoring and auditing can assure quality
Conducting clinical studies is a complex endeavor, involving oversight of clinical investigators with respect to the protocol, Good Clinical Practices (GCP), governing regulations, conditions of Institutional Review Boards and/or Ethics Committees, and institutional Standard Operating Procedures before, during and after conduct of the study. Clinical study data that are generated must be of the highest quality; data must be accurate and evaluable in support of marketing clearance/product approval and collected in a manner that protects the rights, safety and welfare of properly consented trial participants. Both monitoring and auditing can provide this oversight, albeit in different ways.
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