By Kristina Lopienski, Product Marketing Manager, Forte Research Systems, Inc.
At last! Partnerships in Clinical Trials has finally arrived, and there is plenty of excitement here in Boston. To kick off the pre-conference day were four great workshops. One of the tracks, Risk-Based Study Management, featured several presenters who were able to share each of their experiences in planning for and implementing risk based monitoring (RBM).
In his presentation titled, “The A to Z of RBM”, Andy Lawton, Global Head of Clinical Data Management at Boehringer Ingelheim, spoke on the key elements of risk management. He talked about the holistic Integrated Quality and Risk Management Plan (IQRMP), which focuses on detailing what the risks are and how to mitigate them. Andy stressed the need to incorporate feedback from as many people and perspectives for the best risk assessment possible, and so that it’s not just one person’s view.
Since no site or trial will go 100 percent error-free, it’s important to define targets for tolerance (e.g., what’s an acceptable number of missing events, the expected percentage of inclusion/exclusion violations, etc.), and then measure against those. Andy also spoke on using a tailored approach to monitoring based on the overall site risk score, specific site triggers for actions, among many other factors that help determine where and how to focus monitoring attention.
Of course, the monitoring activities include source data verification (SDV), or the direct comparison of the CRF data to the source document to detect data transcription errors, as well as source data review (SDR), a much more comprehensive review of the subject’s data across visits. SDR includes reviewing the quality of source documents (if they meet Good Documentation Practices and ALCOA criteria), ensuring source documents confirm compliance to the protocol and show PI oversight, and verifying that everything remains consistent throughout the trial. While there is still some confusion surrounding these definitions, Andy compared SDV to QC, where SDR is like QA. He talked about getting away from 100 percent SDV so that monitors can free up their time and focus on what really matters.
Ellen Kelso, Executive Director, Strategic Development of Chesapeake IRB, followed, and informed the audience, “We are more alike than you think.” IRBs have long operated with RBM concepts, and she views RBM as an opportunity to enable more effective IRB oversight and a more proactive approach for identifying noncompliance. Ellen mentioned that IRBs are a stakeholder in the process, and sponsors should engage with IRBs to receive and share learning.
Through this workshop, it became clear that it’s important to involve several groups and incorporate their feedback into planning and implementing RBM.
Stay tuned for more coverage on Partnerships in Clinical Trials! You can follow the conference activities on Twitter using the hashtag #PCTUS
About the Author: Kristina Lopienski is the Product Marketing Manager for Overture EDC at Forte Research Systems. In her role, she works to bring educational resources to clinical research professionals. She writes on a variety of topics affecting clinical trials on the Forte Clinical Research Blog. Kristina is currently the guest blogger covering Partnerships in Clinical Trials 2015.