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.

1. Welcome
RISK BASED MONITORING IN CLINICAL
TRIALS
Divya Durga Bollu
Mpharmacy(Pharmaceutics)
045/0323
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
1

2. Index
 Introduction
 Definition of Risk Based Monitoring
 Risk Based Monitoring is it better?
 Key Components Of RBQM
 Monitoring Process
 Benefits of RBM in Clinical Trials and RBM Process
 Conclusion
 References
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
2

3. Introduction
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
3
Risk-based monitoring (RBM) is an approach to clinical trials that uses data from previously conducted studies to
predict the risk of a patient experiencing certain side effects. This method helps ensure the safety of patients by
identifying and minimizing risks at the start of the study as well as continuously evaluating these risks throughout
the study duration. In addition, RBM performs extensive research into all aspects of study design, including:
•Protocol development
•Study conduct
•Clinical research sites
This approach allows sponsors to identify potential issues as early as possible so that corrective actions can be
taken before there is any impact on patient safety, data integrity, or quality control from missing data or poor
documentation of patient events.

4. Definition Of Risk Based Monitoring
Risk-based monitoring is the process of ensuring the quality of clinical trials by identifying, assessing,
monitoring and mitigating the risks that could affect the quality or safety of a study. Guidance from the US
Food and Drug Administration (FDA) outlines three steps in a risk-based approach to monitoring:
• Identify critical data and processes. To accurately monitor the quality of a study and the safety of its
participants, the sponsor must know which elements are most important for each particular study – from
informed consent to eligibility screening and tracking of adverse events.
• Perform a risk assessment. A risk assessment involves determining specific sources of risk and the effect
of study errors on those risks.
• Develop a monitoring plan. According to FDA's guidance, a monitoring plan should "describe the
monitoring methods, responsibilities, and requirements of the trial." The plan is responsible for
communicating risks and monitoring procedures to everyone involved in monitoring the trial.
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
4

5. Risk based monitoring is it better?
One primary feature of risk-based monitoring is its use of centralized monitoring techniques. As opposed to on-site
monitoring based on 100% source data verification, centralized monitoring promises a number of benefits:
• Fewer errors. On-site monitoring methods, like any manual effort, are limited in scope and prone to error.
Risk-based, centralized monitoring uses more automated reviews to determine the need for manual intervention
and is more likely to uncover errors.
• Lower cost. With centralized monitoring, activities like on-site audits can be limited to study sites where
problems are most likely occurring, which can dramatically reduce the cost of monitoring.
• Better analysis. With all data flowing into a central risk dashboard, statistical and graphical checks can much
more easily be used to determine the presence of outliers or unusual patterns in the data.
• Cross-site comparison. Centralized monitoring also allows you to compare data between sites to assess
performance, identify potentially fraudulent data, or locate faulty or miscalibrated equipment.
• More timely results. A dashboard also makes it possible to identify and resolve issues while the trial is
ongoing. Here.
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
5

6. Key Components Of RBQM
1. Initial Cross-functional Risk Assessment—Involves multiple stakeholders and identifies critical-to-quality (critical data
and critical process) risks across the entire trial lifecycle as well as mitigation strategies, which will inform project plans.
2. Ongoing Cross-functional Risk Assessment—A continuous process of revisiting and adjusting the initial risk assessment
and planned mitigations as the trial proceeds based on incoming data and any new developments within or outside of the
trial that could affect quality.
3. Quality Tolerance Limits (QTLs)—Pre-determined limits for specific trial parameters that, when reached, signal that
further evaluation is needed to determine if action is warranted.
4. Key Risk Indicators (KRIs)—Metrics used to assess site performance, either compared to other sites or to established
values.
5. Centralized Monitoring—The remote review of aggregated electronic data, including data analysis.
6. Off-Site/Remote-site Monitoring—Replacement of some or all on-site monitoring visits with remote-site monitoring
visits, where and when allowed by regulatory authorities. When monitoring remotely, a targeted and/or triggered review of
documents and data is used.
7. Reduced SDV—Shift from 100% SDV to more targeted monitoring.
8. Reduced SDR—Shift from 100% SDR to more targeted monitoring.
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
6

7. Monitoring Process
As discussed above, the FDA has provided some detailed guidance on how to prepare a monitoring plan, but once the plan is in
place, it's the sponsor's responsibility (or the sponsor's delegate, like a CRO) to execute the plan. While specifics will differ widely
between studies, a risk-oriented monitoring program will typically contain the following activities, which all flow through a
comprehensive risk dashboard built for your particular study:
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
7
A risk-based monitoring process feeds data from study sites into a dashboard, which then alerts the
sponsor to situations that need further investigation.

8. 5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
8
Data collection and submission. A centralized approach requires a steady and reliable flow of data from each study site to the central
monitoring system. This may occur either through manual entry and transfer of relevant data, or through an automated connection
between the data entry system and the central dashboard.
Dashboard monitoring. The function of the dashboard is to provide, at a glance, information about the status of each study site relative
to the specific risk factors in your trial. When a site shows a high risk level, your monitoring plan should help you decide whether
further investigation is appropriate, from in-depth statistical analysis to on-site data verification.
Statistical analysis. In addition to monitoring your risk dashboard, it can also be useful to perform supplementary statistical
analyses to help identify problems. Simple histograms and box plots can be extremely useful for spotting outliers between
sites or countries for various risk indicators.
Targeted on-site investigation. Dashboard monitoring and further analysis will sometimes signal strongly that in-person
investigation is needed at a particular site. In these cases, it may be appropriate to visit and perform a more traditional
source data verification activity, depending on the nature of your study.
Risk Dashboard. The risk dashboard itself is the center of a risk-based monitoring program. All study data should flow into
the dashboard, and the dashboard should be designed to provide obvious visual cues for high-risk trial sites.

9. 5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
9
Benefits of RBM in Clinical Trials and RBM
Process
By using a systematic approach to monitor patient safety and data quality, risk-based monitoring is able to improve
clinical trial quality, efficiency and compliance with good clinical practice (GCP).
Benefits of RBM in respect to the overall trial conduct include:
• Prioritize patient safety by identifying problems early so that they can be addressed before serious harm occurs. This
helps protect the integrity of your trial data from bias or error.
• Efficiently utilize resources by allowing you to focus on areas where there are higher risks for errors or problems
rather than spending time on every aspect equally.
• Help to reduce the overall costs associated with clinical trials.
• Provide more efficient monitoring by combining activities into one report instead of multiple reports.
• Increase efficiency by automating processes such as form completion and data entry into electronic systems.
• Improve patient experience through real-time data collection from any location at any time via mobile devices or web
portals.

10. Conclusion
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
10
We’ve explored the question of what is risk-based monitoring in clinical trials and why it’s
important?
Risk-based monitoring is a great method to reduce costs and increase efficiency for your clinical
trial.
It can also help keep you on track with your trial goals.
It allows you to monitor only those parameters that are most relevant, providing a cost effective
means of improving quality control while ensuring that you stay within budget.
As such, RBM is an important tool for both sponsors and patients alike; they want the research
conducted safely while also being cost efficient.

11. References
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
11
• https://www.jmp.com/en_in/software/clinical-data-analysis-software/risk-based-monitoring.html
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8082746/
• https://vial.com/blog/articles/what-is-risk-based-monitoring-in-clinical-trials-and-why-is-it-
important/

12. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
5/6/2023 www.clinosol.com | follow us on social media
@clinosolresearch
12