Section 3

Best Practices for Implementation

Responsibilities Within a RBM Plan

Risk Indicators and Thresholds

Technology Guidance

Data Integrity


Pace of Adoption

Responsibilities Within a RBM Plan

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A comprehensive risk-based monitoring (RBM) plan has the potential to predict, control and prevent where possible areas of risk that can derail a clinical trial. Successful adoption requires that each member of the clinical trial team has a clear understanding of their roles and expectations from the outset of the trial.

Development and implementation of a strong RBM plan requires expertise from multiple functions; moreover, the shift towards On-site, Off-site and Centralized monitoring relies on the skills of team members and the well-defined roles that they must work within. In this section, we’ll look at specific responsibilities associated within each type of monitoring.


How do certain responsibilities and activities contribute to RBM?

RBM requires the cohesion of multiple roles, working together toward the common goal of proactive risk assessment. Functional roles involved, beyond the monitors, are data managers, statisticians and medical staff. The below are typical activities falling under each category. When conducting RBM activities, sponsor companies should consider how these new responsibilities may either call for new roles or tie into existing ones.

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  • Coordinating with the sites to manage risks identified during early risk assessment and Centralized monitoring
  • Following up with sites as part of the site management activities
  • Supporting inquiry management
  • Completing various types of data review activities
  • On-site monitoring activities are conducted based on:
    • Timing of study activities, such as the Site Initiation Visit
    • Workload, such as the SDV process
    • Interventions to address issues or risks, assessed by the use of targeted Risk Indicators
  • Overseeing risk management at the investigator site
  • Performing Source Data Verification (SDV) and Source Data Review (SDR)
  • Like with Off-Site monitoring, focused on critical processes, as well as critical data related to eligibility criteria, primary and secondary efficacy and safety end points, and key protocol procedures
  • Engaging and coordinates in person with site staff
  • Verifying facility and equipment, and overall quality conduct
  • Monitoring data quality and critical data reporting
  • Enacting proactive and early identification of quality, safety and operational risks based on the continuous monitoring of data and the risk indicators
  • Tracking site performance metrics
  • Triggering proposed site contacts and on-site visits based on issues that are identified

Within the various monitoring activities, individuals must make sure that sites are adhering to the protocol, improving the likelihood that a sponsor company is going to have interpretable results from a study.1


Additional Findings on Responsibilities 

In the second quarter of 2015, TransCelerate conducted a blinded survey of its participating Member Companies to ascertain best practices associated with Centralized monitoring and feedback on people and processes. 1

Responses uncovered skills and competencies considered essential to the Centralized monitor role.1 Those include:

  1. Clear communication
  2. Leadership
  3. Knowledge and experience of site operations and data management
  4. Keen comprehension of the assessment and management of risks, including the ability to analyze aggregated data and interpret risk indicators to evaluate site performance and data quality

In most instances, individuals performing Centralized monitoring activities were recruited from internal departments of the sponsor company, and included people with experience in clinical operations, data management, statistics, quality or systems support. Some Member Companies reported having created a new role specifically for the Centralized monitor, while others assign the key responsibilities among existing roles.

Overall, the survey results suggest that sponsor companies feel that clinical science/medical, data management, statistics, clinical operations and According to the World Health Organization (WHO), the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other related drug problems.2pharmacovigilance functions all must work collaboratively to establish a cohesive process for managing clinical trial risk effectively.

1. Therapeutic Innovation & Regulatory Science, “Defining a Central Monitoring Capability: Sharing the Experience of TransCelerate BioPharma’s Approach, Part 2.” Jacqueline Gough, Brett Wilson, Mireille Zerola, Phil Wallis, Laila Mork, David Knepper, Heather Achenbach

Section 3: Best Practices for Implementation

Risk Indicators and Thresholds