Role of Clinical Data Management in Risk-Based Monitoring

Introduction:

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.

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.

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.

Conclusion:

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.

References:

• 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-itimportant/

Student Name: G.Sudheer

Qualification:B. Pharmacy

e-Mail ID:guthikondasudheer10@gmail.com