Section 1

What is Risk-Based Monitoring (RBM)?

Introduction

Backdrop: Challenges and Opportunities for Clinical Trials

The Discussion: On-site, Off-site and Centralized Monitoring in Clinical Trials

Benefits of RBM

Introduction

Download a PDF of the RBM Interactive Guide

Clinical trials play a critical role in the development and delivery of breakthrough medical treatments. They evaluate which drugs, devices and treatments are safe and effective for humans, and which therapies work best for certain illnesses or patient populations. Successful trials require quality data, protection of patient safety, affordability and speed.

This guide focuses on a modernized, proactive method of clinical trial monitoring called risk-based monitoring (RBM), an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.

Section 1: What is Risk-Based Monitoring (RBM)?

Backdrop: Challenges and Opportunities for Clinical Trials