Risk-based monitoring (RBM) is an adaptive approach that focuses monitoring activities on areas most likely to impact patient safety and data quality, rather than uniform monitoring of all sites. It uses a risk assessment to determine each trial's customized monitoring plan. Key steps in RBM include defining risks, selecting key risk indicators and thresholds, determining action recommendations, and continuously reviewing and adjusting the plan. RBM relies on technology and qualitative and quantitative data to evaluate metrics like timelines, efficiencies, and quality.
With the regulators moving forward with guidance on risk based monitoring, and the industry trend of
adopting this approach, this presentation will aim to demonstrate how the combination of CTMS, EDC
and analytics can be used to identify and manage site risk profiles. The presentation will draw from the
work completed by the MCC members and show how the Site Scoring tools for Site Selection and Study
Conduct can be used to generate a risk profile dashboard based on data from CTMS and EDC. The
presentation will further explore how data captured in CTMS and EDC can be used to update the risk
profile of the site during the course of the study, allowing the study team to proactively manage risk.
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDMwww.datatrak.com
Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
With the regulators moving forward with guidance on risk based monitoring, and the industry trend of
adopting this approach, this presentation will aim to demonstrate how the combination of CTMS, EDC
and analytics can be used to identify and manage site risk profiles. The presentation will draw from the
work completed by the MCC members and show how the Site Scoring tools for Site Selection and Study
Conduct can be used to generate a risk profile dashboard based on data from CTMS and EDC. The
presentation will further explore how data captured in CTMS and EDC can be used to update the risk
profile of the site during the course of the study, allowing the study team to proactively manage risk.
Risk based monitoring presentation into what Risk Based Monitoring (RBM) is all about. The value of getting it right, and the risks of getting it wrong. We look at the Triumph Research Intelligence (TRI) approach to RBM, and the TRI solution to RBM. An insight into the Future of Visual OPRA is given.
How To Optimize Your EDC Solution For Risk Based Monitoringwww.datatrak.com
This presentation presents best training practices to leverage EDC technology and risk-based monitoring to effectively and efficiently monitor clinical research.
Our focus is on the practical process of preparing your team to optimize the tools made available through an EDC solution.
This presentation is applicable to CRA’s, clinical project managers, clinical data managers, regulatory compliance professionals, and those involved in the design and implementation of risked-based monitoring plans.
Presentation delivered by Lori A. Tierney, BSN, Director, Site Management Operations, Allergan, Inc. at the marcus evans Evolution Summit Fall 2019 in San Diego CA.
The FDA Guidance of a Risk-Based Approach to Monitoring as Viewed By CDMwww.datatrak.com
Historical Perspectives in CDM
Overview of the Draft Guidance
A Risked-Based Approach
Challenges to a Risk-Based Approach
Supporting a Risked-Based Approach
After reviewing the FDA regulations on Risk Based Monitoring, review the details on how to put the principles into action! We include two reference documents to help you get started... and to make it a success.
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
How to Prioritize Risks with Qualitative
and Quantitative Risk analysis based on PMBOK6. Difference between Quantitative Risk analysis and Qualitative Risk Analysis.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
In the course of any clinical trial, there are risks associated with specific activities and tasks. This webinar will highlight some of these key risk areas and provide guidance on combining technology with best practices to help mitigate risks.
Niki Kutac, Director Product Management, delivered this presentation at the ACRP 2014 Conference where it was rated the #1 Session of the Event. Learn how to implement gamification to produce the desired end result.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
How to Prioritize Risks with Qualitative
and Quantitative Risk analysis based on PMBOK6. Difference between Quantitative Risk analysis and Qualitative Risk Analysis.
hello there , During M pharm , I have presented this for seminar purpose named as '' QUALITY RISK MANAGEMENT " Hope it will reach your expectations. thank you.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
In the course of any clinical trial, there are risks associated with specific activities and tasks. This webinar will highlight some of these key risk areas and provide guidance on combining technology with best practices to help mitigate risks.
Risk Based Monitoring in Clinical Trials.ClinosolIndia
Risk-based monitoring (RBM) is a monitoring strategy in clinical trials that aims to improve the quality and efficiency of data collection while reducing costs and burden on study participants. Rather than conducting monitoring activities at fixed intervals, RBM utilizes a risk assessment approach to identify areas of the study that are at higher risk of errors or deviations from the protocol and focuses monitoring efforts on those areas.
The RBM process begins with a risk assessment, which involves identifying potential risks to the study's data integrity, participant safety, and study conduct. This may include risks related to patient enrollment, data collection, adverse event reporting, or protocol compliance. Based on the risk assessment, the study team creates a risk management plan that outlines the monitoring strategy to be employed throughout the trial.
In RBM, monitoring activities are targeted to focus on the areas of the study that present the highest risk. For example, if a study has a high risk of data entry errors, the monitoring plan may include a more intensive review of data entry activities or require that data be entered in real-time, so errors can be identified and corrected more quickly.
RBM can be facilitated through several tools, such as centralized monitoring, key risk indicator (KRI) dashboards, or data analytics. Centralized monitoring allows for remote review of study data by a team of experts who can identify trends and issues more efficiently. KRIs are pre-defined metrics used to track performance and detect areas of concern, allowing for proactive management of risks. Data analytics can identify unusual patterns or outliers in the data, enabling the study team to focus on those areas of concern.
RBM is a dynamic process that involves ongoing evaluation of the study's risk profile and adjusting the monitoring strategy accordingly. By focusing monitoring efforts on the areas of the study that pose the highest risk, RBM can improve data quality and participant safety, while reducing monitoring costs and burden.
Leveraging Siebel CTMS for Risk-Based MonitoringPerficient, Inc.
In a risk-based monitoring (RBM) strategy, rather than treating all clinical sites and source data equally, monitoring resources are focused on the sites that need the most help, and the data that is most critical to the study or most likely to have issues.
Because RBM is so effective at saving time, reducing costs, and improving quality, sponsors and contract research organizations are working to make the switch. While doing so may not be easy, companies with Oracle’s Siebel Clinical Trial Management System (CTMS) will have a leg up on the competition.
Learn how you can configure and leverage Siebel CTMS to support an RBM strategy.
Overview of Risk Based Monitoring in Clinical Trial ProcessesEditorIJTSRD1
Risk based monitoring RBM has emerged as a transformative approach in clinical trial processes. This paper provides an overview of RBM and its impact on the field of clinical research. By moving away from traditional on site monitoring and adopting a targeted and efficient approach, RBM has demonstrated numerous benefits in terms of cost effectiveness, data quality, and patient safety. This abstract summarizes the key findings discussed in the conclusion. The proactive identification and management of risks throughout the trial lifecycle have led to improved decision making, increased study participant compliance, and enhanced overall trial success rates. With advancing technology, RBM approaches are expected to evolve further, allowing for greater optimization and streamlining of clinical trial processes. The abstract concludes by emphasizing the potential of risk based monitoring to shape the future of clinical research and contribute to the development of safe and effective therapies for patients worldwide. Kelam Himasri | Sankara Narayanan. K "Overview of Risk-Based Monitoring in Clinical Trial Processes" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-3 , June 2023, URL: https://www.ijtsrd.com.com/papers/ijtsrd58586.pdf Paper URL: https://www.ijtsrd.com.com/pharmacy/pharmacy-practice/58586/overview-of-riskbased-monitoring-in-clinical-trial-processes/kelam-himasri
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
TRI was founded as a subsidiary of Triumph Consultancy Services in 2013, following 12 years of consulting to the clinical trial industry. TRI has been evaluating the specific challenges facing the industry when implementing a risk-based monitoring strategy and the various approaches and products being utilized by organizations as they move into the RBM arena. This paper aims to summarize our findings and provide guidance as to how the main challenges can be overcome.
Best Practices to Risk Based Data Integrity at Data Integrity Conference, Lon...Bhaswat Chakraborty
Data integrity can be implemented using several approaches. One of the most effective ways to implement DI is a risk based approach. The speaker elaborates this.
Risk Based Monitoring in Clinical trials_Aishwarya Janjale.pptxClinosolIndia
Risk-Based Monitoring (RBM) in clinical trials represents a departure from traditional, one-size-fits-all monitoring approaches. This innovative strategy tailors monitoring activities to the specific risks associated with a trial, optimizing resource utilization and enhancing data quality. This article explores the key principles, benefits, and challenges of RBM, illustrating its transformative impact on the landscape of clinical trial oversight.
Key Principles:
Risk Identification and Assessment:
RBM begins with a comprehensive assessment of potential risks to data integrity, patient safety, and study endpoints. These risks are identified based on factors such as study complexity, patient population, and investigational product characteristics.
Risk-based Monitoring Strategies for Improved Clinical Trial PerformanceCognizant
To address draft regulatory guidance for risk-based clinical trial monitoring, sponsors should consider strategies that utilize social, mobile, analytics and cloud technologies to create responsive methodologies that satisfy both the spirit and the letter of these new guidelines.
Data Management: Alternative Models for Source Data VerificationKCR
KCR's presentation on alternative models for Source Data Verification (SDV) Risk Based Monitoring (RBM) is evolving into a standard expectation for SDV and study management in general.