Quality

Planning for Quality in Medical Device Clinical Trials

Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional on-site monitoring to risk-based monitoring requires cross-functional collaboration and careful planning.

Risk-based monitoring is a comprehensive approach to clinical trial monitoring that focuses on proactively identifying and addressing risks to patient safety and data quality. Effectively navigating the shift from traditional on-site monitoring to risk-based monitoring requires cross-functional collaboration and careful planning.

For more than a decade, the concept of RBM has been discussed, implemented, and refined in the pharmaceutical and medical device worlds. While most large manufacturers in the medical device industry have incorporated RBM into their clinical trials, smaller medical device companies have been slower to embrace the concept.

The recent revision of the ICH Guideline for Good Clinical Practice E6 (R2) from 2016 puts RBM back in the spotlight. In addition, the upcoming new version of the ISO 14155 standard for medical device clinical investigations and Good Clinical Practice will emphasize that RBM is more relevant and necessary than ever.

In this white paper, we discuss RBM and explore how to effectively implement this monitoring approach into medical device clinical trials in a methodical and compliant manner.

The trend toward risk-based monitoring

RBM is an indicator of quality in a clinical trial and allows for a more in-depth assessment of site data, without requiring additional time on site. In recent years, both regulatory and industry guidelines have been promoting a risk-based approach to clinical trial monitoring.

FDA: Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring

A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Guidance for Industry

These guidance documents assist sponsors in developing risk-based monitoring strategies that enhance human subject protection and clinical trial data quality by focusing oversight on the most important aspects of clinical trial conduct and reporting. The FDA recommends a quality risk management approach and emphasizes that quality is an overarching objective that must be built into the clinical trial enterprise.

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