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In November 2016, the first revision of the ICH GCP guidelines in 20 years were finalized and ICH E6 (R2) was published. This addendum contained 26 changes, 16 of which apply specifically to sponsors.


Important requirements based on changes within ICH E6 (R2):

  • Use data and pre-established tolerance limits for decision making
  • Execute routine risk reviews
  • Minimize risk through planning; early signaling and mitigation of problems
  • Provide oversight commensurate with risks that matter
  • Complete end of trial report on effectiveness of risk management
  • Risk review requires traceability of decision making


In a recent survey, 20% of sponsors – and even fewer providers – reported using technology for any of the following specific activities that support risk-based activities*:

  • Data integration and oversight
  • Data visualization
  • Centralized statistical monitoring/testing
  • Decision analytics to assess risks and potential impacts

* 2017 Avoca Industry Research Survey


Avoca Makes It Easy to Implement ICH E6 (R2)

The Avoca Quality Consortium addresses ICH E6 (R2) requirements via an online and searchable Knowledge Center consisting of leading practices, guidelines, tools, templates, and process documents to support ICH E6 (R2) implementation. Specific documents directly address risk-based approaches. These tools take a step-wise approach to implementing ICH E6 (R2) by breaking it down by its subcomponents.


12 Steps to ICH E6 (R2) Compliance

Process Map and Number of Tools in the AQC Knowledge Center


AQC Quality Agreement Template

The AQC Quality Agreement is one of the many guides that can be found in the AQC Inspection Readiness knowledgebase. It is designed to operationalize detailed conversations about quality and oversight expectations between sponsors and providers. Built as a template, it helps users record and track compliance with ICH E6 (R2).

Download the AQC Quality Agreement Template


AQC Quality Agreement Template Table of Contents


Click to enlarge.


For more information about the AQC or how Avoca can help you implement ICH E6 (R2), contact us today!