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

June 6, 2016
Nick Neri

This 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 1 covers the addendums implications, objectives, requirements and advantages.

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.   Part 1:  Overview of the ICH E6 (R2) Addendum   The International Conference on Harmonisation’s (ICH) addendum to the ICH E6 Guideline for Good Clinical Practice has many implications for clinical trial sponsors and contract research organizations (CROs).  The 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.   One of ICH’s objectives with this addendum is to harmonize existing guidance from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and others, which they believe are not currently aligned. The resulting lack of harmonization has left much room for interpretation, which can be confusing for organizations striving to meet regulatory requirements on a global scale.    The addendum will require most biopharmaceutical companies and CROs to make significant changes to their risk culture and technology in order to be compliant, including the suggestion to implement a combination of on-site and centralized monitoring, and that the rationale behind each approach be documented.    Centralized monitoring is critical for optimizing data quality in today’s complex clinical research landscape and, with the right tools in place, easily operationalized as sponsors and CROs strive to meet these important guidelines.   Change is Opportunity  There are many advantages to implementing a centralized Quality Risk Management (QRM) system in addition to driving compliance with the new ICH standard. Centralization can also significantly cut the time and cost of clinical trials while helping to reduce risks. Yet most organizations are behind the curve when it comes to implementing the technology and processes needed to adhere to this new guideline change, and that may be putting them at risk.   This change is likely to go into effect by the end of 2016, which means organizations that haven’t started transforming their risk monitoring process are already falling behind. To catch up, biopharma stakeholders need to take the time now to read the addendum in full, define the impact it will have on the way they conduct trials, and devise a plan to adapt their technology and risk management practices so they can meet coming regulations while benefitting from a more centralized approach to managing clinical trial risk.   Look for Part 2 of the series next week: ‘6 Steps to Complying with the ICH E6 (R2) Addendum’   Nick Neri is the Insights Cloud Platform Manager for ERT

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