ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?


Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.

Patrick Hughes, co-founder, chief commercial officer, CluePoints

Patrick Hughes, co-founder, chief commercial officer, CluePoints

The ICH E6(R3) draft guideline document1, currently open to public consultation, places the industry firmly in the risk-based era, making it clear that the benefits of comprehensive operational oversight and targeted data management are in no way limited to the process of monitoring alone.

Yet a new study presented by Ken Getz during the event, conducted by the Tufts Center for the Study of Drug Development, CluePoints, and Price Waterhouse Cooper, showed 78% of participants trust that RBQM will improve clinical trial quality; however, just 55% of organizations have started their risk-based quality management (RBQM) journey, and that everyone was at a different stage of adoption. Indeed, while 60% of RBQM-utilizing organizations use the approaches in the documentation and resolution stage, only 51% have implemented such approaches in study execution.

The work, which included a survey of more than 200 people and an international series of round-table discussions with RBQM executives, also highlighted that different organizations have varying definitions of RBQM. For some, it was as simple as reducing manual source data verification (SDV), while others saw it as an end-to-end risk-based approach that spanned various functional areas of the business.

ICH E6(R3) goes someway to providing a clear definition. It ties the concepts of Quality by Design (QbD) and RBQM into a single process, discussing risk assessment, risk mitigation strategy planning, and risk detection. However, there are still some areas that require further clarification.

It no longer, for example, includes a specific reference to quality tolerance limits (QTL), an element of ICH E6(R2) that has caused much discussion and contention across the industry. However, while the term is not used explicitly, the language used to describe “acceptable ranges” mirrors what was previously used to define QTLs in R2.

For these thresholds to be robust and appropriate, they will need to be indication-specific, consistent, and evidence-based. This will require data and the kind of cross-sector collaboration we have already witnessed and advocate.

Through events like DIA Global, sponsors, contract research organizations (CROs), and others have already shown they have the ability and the appetite to work together to advance the discipline of clinical trial management for the good of medical science.


1. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf

To download the initial Impact Report, after registration, please visit https://lp.cluepoints.com/tufts-impact-report. To purchase and download the Impact Report from Tufts, please visit https://csdd.tufts.edu/impact-reports.

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