Risk Based Monitoring Resource Community
Check out all the latest articles, conferences, multimedia and more around risk-based monitoring!
Cost and Quality Implications for RBMSource data verification (SDV) remains a concept that many sponsors, CROs and sites take to heart. The 100% SDV approach, in fact, is believed to have evolved over the years as an FDA requirement. FDA itself admitted in its August 2011 Draft Guidance for Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, that a CTTI study found that companies typically conduct on-site monitoring visits at four to eight-week intervals because of the perception that the frequent on-site monitoring model with 100% SDV is the FDA’s preferred way for the sponsors to meet their monitoring obligations.
MORE ARTICLES
- Medidata and PPD Partner to Offer New Approach to Risk-Based Monitoring
- Conquering RBM: A Story on Medtronic's Risk Based Management Methodology
- Cluepoints Statistical Monitoring Used to Check Data Quality in Large Phase III Trial
- Shifting Monitoring Paradigms: Challenges and Opportunities
- JMP and SAS: Tech Behind RBM Analytics
- MCC Metric of the Month: A 2nd Risk-Based Monitoring Metric
- Objective Internal Monitoring Can Improve Trial Conduct
- Cost and Quality Implications of RBM
- RBM, Proactively Managing the Present
- Risk-Based Monitoring: Pilot Projects, FSPs and Integrated Solutions
- BioClinica Acquisition Adds RBM to eClinical
- MCC Offers In-Depth Study of Risk-Based Monitoring Practices
- CluePoints Offers Web Application for RBM
- Competencies for Changing the Role of the Study Monitor
- Centralized Statistical Monitoring as a Way to Improve the Quality of Clinical Data
- PAREXEL Launches Perceptive MyTrials Data-Driven Monitoring
- Medidata and TransCelerate BioPharma Join on Risk-Based Monitoring Methodology
- Competencies for the Changing Role of the Clinical Study Monitor: Implementing A Risk-Based Approach to Monitoring
- MCC Metric of the Month Blog: A Risk-Based Monitoring Metric
- Amgen's FSP Model & RBM: Doing it Right?
- How Bristol-Myers Squibb is doing Risk-Based Monitoring
- TransCelerate Updates RBM Pilot
- Time to Change the Clinical Trial Monitoring Paradigm
- Time to Embrace Risk-Based Monitoring
- Risk-Based Monitoring: Answers from a Recent Webcast
- Case Study: Confirmation of Fraud - Diaries Completed by Staff
- ICON Exec Discusses ICONIK Monitoring
- Triumph's Recap of CBI's Risk-Based Monitoring 2013
- Is Your RBM Strategy Missing a Critical Link?
- Tips on Writing Risk-Based Monitoring Plans
- RBM: You Can't Get There from Here
- Higher Quality at Lower Cost: The Benefits of Portfolio-Wide Predictive Analytics in Clinical Trial Monitoring
- FDA Updates Current Thinking on Risk-Based Monitoring
- Operational Change and RBM
- The Qs of Risk-Based Monitoring
- How Under-Utilized Data Becomes RBM Solution
- Distinct RBM Divisions: Source Document Verification and Source Data Review
- Risk-based Approach to Monitoring
- TransCelerate's Risk Based Monitoring Goes on Tour
- ISR Reviews Report "Risk-based Monitoring: Industry Guidance on Adoption, Use, and Outsourcing"
- What Do Risk-Based Monitoring and Patient Engagement Have in Common?
- Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?
- Increasing Intensity of On-Site Monitoring a Troubling Trend
- Industry Metric Indicates Low ROI with Full Source Document Verification
- Snapshot Shows Targeted Site Monitoring Trend
- Targeting Source Document Verification
- Triggered Monitoring - Moving beyond a standard practice to a risk based approach that can save sponsors time and money
- Risk-Based Monitoring: An Opportunity to Go Back to Basics
- Risk Based Monitoring: A Primer for Small to Mid-size Sponsors
- What Can We Expect from TransCelerate?
Risk-Based Monitoring in Clinical StudiesNovember 6–7, 2014 | Philadelphia, Pennsylvania
This is the only event dedicated to providing real life examples, lively discussion and practical suggestions on how to implement and fully execute a RBM program. Don't miss the opportunity to particate in progressive discussions on all things RBM and leave with actionable insights on executing risk-based monitoring programs.
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ON-DEMAND WEBCAST: Editors' Series: Monitoring Clinical Trials – Models, Myths and Momentum
This webcast will look at the current state of clinical monitoring through recent surveys; discuss the various models under the umbrella term of "risk-based monitoring" and highlight many of the challenges and barriers to changing monitoring models.
Monitoring With the ICONIK Platform
Nuala Murphy, Executive Vice President, Global Clinical and Data Operations for ICON Clinical Research discusses how monitoring works with the ICONIK platform with Editorial Director Lisa Henderson
How RBM Impacts the Way Sanofi Handles Monitoring
Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring
RBM for CRAs and Site Monitors
Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring
TransCelerate Methodology
Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and its impact on the clinical trials industry and risk-based monitoring
Sponsor Buy-in for the TransCelerate Concept
Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and its impact on the clinical trials industry and risk-based monitoring
The Evolution of TransCelerate
Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and its impact on the clinical trials industry and risk-based monitoring
How TransCelerate Helps the Industry
Craig Wozniak, head Americas region, clinical operations at GlaxoSmithKline, discusses TransCelerate and it's impact on the clinical trials industry and risk-based monitoring
What is Different Now About Risk-Based Monitoring
Jules Mitchel of Target Health discusses What is different now about risk-based monitoring vs. what companies may have been doing more innovatively about monitoring in the past in the clinical trials industry
Jules Mitchel: Thoughts on Risk-Based Monitoring
Jules Mitchel of Target Health discusses risk-based monitoring trends in the clinical trials industry
A Perspective on Risk Based Monitoring
Editorial Director Lisa Henderson talks with Steve Powell, PRA executive VP clinical informatics and late phase services about risk-based monitoring (RBM)
The Data Can Speak for Itself - The Role in Biostatistics in Clinical Trials
Listen to this podcast to learn all about the history of CluePoints' development from CluePoint Founder Marc Buyse with a discussion of the role of biostatistics
TOOLS & RESOURCES
FREE! Risk-Based Monitoring in Clinical Studies Compendia
View presentations from CBI's Risk-Based Monitoring in Clinical Studies conference. Learn about the transformation of clinical trials through RBM and direct data entry and many other topics, all in this handy guide.
Designing Risk Detection Metrics for Risk-Based Monitoring
Click here to access an RBM position paper released by Triumph Research Intelligence.
Risk-based Monitoring: Industry Guidance on Adoption, Use and Outsourcing (paid report), ISR Reports
Risk-based Monitoring: Reduce Clinical Trial Costs While Protecting Safety and Quality (requires registration)
HELPFUL LINKS
- FDA Guidance: Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring
- EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials
Reflection paper on risk-based quality management in
clinical trials.
- TransCelerate BioPharma Position Paper: Risk-Based Monitoring Methodology
TransCelerate's RBM methodology describes the steps taken to assess risk, to determine Critical Data and Processes, and to mitigate those risks through the utilization of the Integrated Quality Risk Management Plan (IQRMP). Well-designed protocols and case report forms (CRFs) are considered important foundational influencers with an impact on quality and efficient monitoring.