Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices — PDF
The biggest driving factor behind implementing risk-based monitoring (RBM) of clinical trials is savings. Centralized monitoring of trial sites based on risk profile is cheaper, less resource-intensive and, ultimately, more efficient.
But consider this: trials that are using RBM have found that it increases the effectiveness of quality control as well as data accuracy, according to a recent survey by QuintilesIMS. Here are some other key findings:
- The top therapeutic areas using RMB are dermatology, oncology, biologics and immunology;
- Use of RBM in Phase 2 through Phase 4 studies is increasing; and
- RBM users are increasingly shifting from 100 percent on-site monitoring to some degree of remote monitoring.
Most telling of all is that more than half of survey respondents not currently using RBM plan to implement it within the next two years.
The new FDAnews management report Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDA’s requirements.
You'll get specific recommendations about the 5 data points that you must always monitor … 9 essential critical risk factors your monitoring plan must consider … 5 key components that should make up your monitoring plan (and what they each should contain) … and all of the documentation requirements that are absolutely essential to every monitoring plan.
You'll also find out the answers to important questions:
- How do you implement centralized monitoring?
- What metrics should you monitor?
- What constitutes an unusual distribution of data across study sites that might trigger an alarm?
- What are the key metrics that correlate with poor performance and noncompliance?
- What electronic systems need to be in place to incorporate remote monitoring into your risk-based monitoring system?
- What’s the minimum number of site visits you should be conducting, regardless of risk?
- How many different risk levels can a monitoring plan include?
- And more …
This updated report also contains more information on the QuintilesIMS survey’s findings and expert conclusions.
You, too, can start reaping the benefits of RBM. Purchase your copy of Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices TODAY!
Who Will Benefit
- Regulatory affairs
- Clinical Trials Manager
- Research Director