Risk-Based Monitoring: Improving the Clinical Trial Site Experience


Technology forges a world where human connection is no longer inhibited by distance. Barriers are broken and replaced with virtual bridges that create unprecedented potential for an interconnected present and future. And no doubt the areas most affected by this technological nexus are ones dominated by human synergy. An area at the center of this change is the pharmaceutical industry, characterized by technological and medical advancement, but faithfully guided by the necessity to improve the human condition. Clinical trials are at the forefront of pharmaceutical progress and clinical monitoring plays a key role in collecting high-quality trial data. As technology allows risk-based monitoring to become more frequently implemented, changes to the traditional monitoring set-up will occur. This report explores the reverberations of RBM implementation on trial operations as experienced by site personnel.


Report cover for Risk-Based Monitoring: Improving the Clinical Trial Site Experience

Sponsors & CROs

  • High-level perspectives regarding the clinical trial experience through the eyes of the site staff. These findings can be used to understand what drives trial staff as well as what trial-related difficulties they encounter that may be assuaged with implementation of new methodologies.
  • How sites view the role of the CRA, their typical working relationship with CRAs, and the issues they encounter in their CRA interactions.
  • How a risk-based approach to monitoring can affect daily operations at clinical sites.
  • Site personnel’s baseline level of knowledge and reactions to RBM to help sponsors/CROs plan useful conversations with trial staff regarding RBM implementation.
  • Best practices for RBM use as relayed by site staff, including best practices for communication and training. Advice to sites and sponsors/CROs that are implementing a risk-based approach to monitoring.
  • Insights on Running Clinical Trials
  • Perspectives on Monitoring
  • Perspectives on Risk-Based Monitoring
  • Risk-Based Monitoring in Practice
  • Risk-Based Monitoring: Suggestions and Outlook

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Sample page for Risk-Based Monitoring: Improving the Clinical Trial Site Experience

Insights on running clinical trials

Most rewarding aspects of running clinical trials

Patient relationships
Providing treatment options for patients
Shaping the future of medicine
New drug approvals
Working environment

Least rewarding aspects of running clinical trials

Workload/time management
Patient enrollment

Unappealing protocol aspects
Pain points in running trials

Unfamiliar with protocol / changes protocol
High monitor turnover
Key takeaways

Perspectives on monitoring

Role of the monitor

Data check
Information resource
Valued team member

Working with monitors

Frequency of on-site visits
Preparing for on-site visits
Scheduling on-site visits
Communication between site and monitor – traditional monitoring

Effects of monitor turnover
Qualities of a great CRA
Key takeaways

Perspectives on risk-based monitoring

Understanding of RBM
Understanding of centralized monitoring
Reactions to RBM in trial protocol

Monitor support questions
Data requirements concerns

TransCelerate familiariaty
Key takeaways

Risk-based monitoring in practice

Pre-study awareness of RBM approach
Benefits of RBM

Increased focus on data entry timelines
Centralized monitoring efficiency

Drawbacks to RBM

Less data oversight
Weaker monitor relationships

Points of contention

Extra burden vs. time-saver
Reducing costs vs. raising costs

Frequency of on-site visits when using RBM
Sponsor vs. CRO preference
Technology use in RBM studies

Data entry and data checks
Use of multiple systems
EDC training and testing desired
Audit trails

Key takeaways

Risk-based monitoring: suggestions and outlook

Best practices for using RBM

Develop and implement detailed communication plans
Provide sufficient training

Worst practices for using RBM
Suggestions for RBM implementation

Advice for sites
Advice for sponsors/CROs

If you worked at a sponsor/CRO…
RBM consensus
Key takeaways


Organization type
Office location
Clinical research conduct
Clinical research sponsors
Clinical research recency
Primary role
Clinical research trial types
Unaided familiarity with RBM
Unaided familiarity with remote or centralized monitoring
Site experience with RBM
Involvement with RBM trials
Site experience with remote or central monitoring
Involvement with remote or centralized monitoring trials
Number of RBM trials by phase
Number of RBM trials by therapeutic area

Additional information


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