Preparing for the ICH E6 (R2) Addendum: A 3-Part Series


This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 2 covers steps that organizations can take today to begin adopting a centralized technology-based approach to risk management.

This 3-part series is designed to outline the implications and processes for ensuring compliance with ICH E6 (R2) changes that are scheduled to go into effect late 2016.  For an overview of the Addendum see Part 1 of the series, published here on June 6, 2016.   Part 2:  Six steps to compliance with ICH E6 (R2) Addendum   The ICH’s new E6 (R2) addendum to Good Clinical Practice has the potential to change the way clinical monitoring and trial management are conducted by requiring adoption of centralized, quality risk management (QRM) throughout the trial lifecycle.   Trial sponsors and CROs recognize real, measurable benefits from taking a centralized, technology-based approach to risk management. These include reduced on-site monitoring costs, real time identification of risk trends across all trial sites and access to trial-wide views that enable them to capture best practices for future trials.   However, sponsors and CROs have been slow to adopt this centralized approach, likely because it requires some culture and technology transformation which can be difficult for some organizations to undertake. But the ICH addendum will soon be required, so companies need to start taking steps today to ensure compliance and to reap the time and cost savings benefits that come from a centralized technology-based approach to risk management. Here’s how:

  • Read, assemble and plan. Before making any changes, sponsors and CROs should assemble an in-house working group of GCP experts to study the new addendum, determine its full implications to their organizations and make decisions about how to adapt their technology and practices to meet the new requirements.

  • Develop technology and process gap analysis. Once the GCP team defines what compliance looks like for their organization, they should evaluate their current processes and technologies to determine if/where they fall short of the new requirements. For example, they may need to define a more formal risk identification process, create or acquire a library of risk identifiers, and/or replace manual spreadsheets with a more robust, technology-driven solution for assessing risks. This gap analysis will help them define a strategy for change and the steps needed to get there. 

  • Assess existing data systems. Most sponsors and CROs today rely on transactional study data drawn from numerous, diverse data capture systems like EDC, IVRS, Labs, etc. These data are often siloed and rely on unique codes and naming conventions. This lack of integration not only limits the sponsor’s visibility, but also makes it difficult to proactively identify and react to risks. To overcome these shortcomings, organizations should first identify where silos occur, then look for technology solutions that can remove the silos and integrate these systems’ data.  This will provide a single operational view that supports real-time risk monitoring across the entire trial site network.

  • Study it. One of the biggest challenges companies will face is the culture transformation required to change the way risks are identified and managed in clinical research. To ease stakeholders into this new paradigm, organizations can roll out pilot projects with clearly defined metrics to demonstrate value and share case studies of other organizations that have already successfully made the switch. Studies show that a centralized approach reduces monitoring time and costs and often uncovers risks that on-site monitors miss. Demonstrating these benefits using real quantitative outcomes is the best way to engage stakeholders and increase their comfort with the change. 

  • Evaluate your CRO. Regardless of whether a CRO is responsible for all clinical trial activities, the sponsor is still responsible for the quality, safety and efficacy of their processes and data. To ensure compliance with the addendum, sponsors should audit their CRO’s technology and QRM approach to determine if it meets ICH requirements and if not, how the CRO plans to move toward compliance. 

  • Join the discussions. The adoption of risk-based quality management has the potential to disrupt the industry and it has only just begun. To ensure compliance with the addendum and to achieve the greatest benefits, sponsors should look for opportunities to share learnings and participate in industry consortia, including TransCelerate BioPharma and the Clinical Trials Transformation Initiative, as they define standards and best practices for leveraging quality risk management strategies. 


Look for Part 3 of the series next week:  ‘Driving Compliance through Technology: Act Now’

  Nick Neri is the Insights Cloud Platform Manager for ERT

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