ICH E6 R2 – Guidance and road map of tools for navigating the regulatory landscape
The International Conference on Harmonization Addendum to the E6 GCP Guideline, ICH E6 R2, provides a unified standard for the European Union, Japan, United States, Canada, and Switzerland to facilitate mutual acceptance of clinical data by regulatory authorities.
The guideline addresses the need to leverage new technology and risk management processes to increase efficiency and focus on critical activities in clinical trials including oversight. And that’s where the Avoca Quality Consortium’s leading practices, guidelines, and tools come in. Avoca has developed a “Roadmap” to support companies in being compliant with ICH E6 R2, particularly when it comes to ensuring effective oversight and mitigating risk in clinical trials. One example of this is the AQC Quality Agreement Template. This was one of the first deliverables provided to Members of the Avoca Quality Consortium and it is considered to be one of the most valuable and practical in that it not only provides the needed documentation to be compliant with ICH E6 R2 regulations, but also, it operationalizes a detailed conversation between sponsors and providers about quality and oversight expectations. To get a complimentary download of this document, which includes a module on third party oversight (Section 9), click here.
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