Inspection Readiness – Understanding the QMS and ICH E6 R2 for Inspection Readiness
Inspection Readiness is a perennial challenge: how prepared are you? Are you prepared to hand over the login information of your eTMF to an auditor? The concept of risk management has been discussed in the context of clinical research for several years. With the adoption of ICH E6 R2, risk-based quality management for clinical trials has become an obligation. Risk assessment, risk-proportionate oversight, and quality management approaches must be documented, justified, and validated using metrics. This documentation is to be controlled and maintained, as auditors and inspectors, who base their evaluation mainly on ICH-GCP guidelines, will take these risk and quality management approaches into account and determine compliance of the risk-proportionate procedures and processes documented. Risk-proportionate approaches extend even to ascertaining the content of the TMF/eTMF and require that some process documents become essential documents.
The AQC Inspection Readiness segment of the Avoca Quality Consortium Knowledge Center offers side-by-side comparisons of key areas of focus for regulatory agencies as well as a highlight on Member experiences and leading practice tips and suggestions in each of these areas of focus. Additionally, the Avoca Quality Consortium’s leading practices, guidelines, and tools are available to support companies in ICH E6 R2 compliance, particularly when it comes to ensuring effective oversight and mitigating risk in clinical trials by providing powerful strategy, planning, implementation, and documentation tools, templates, and guidelines.
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. This template is one of the most valuable and practical tools because it provides needed documentation to be compliant with ICH E6 R2 regulations and it operationalizes a detailed conversation between sponsors and providers about quality and oversight expectations. To obtain a complimentary download of this document, which includes a module on inspection readiness (Section 11.2), click here.
About the Avoca Quality Consortium (AQC)
The AQC is an industry-wide collaborative that brings together industry stakeholders to improve quality management in outsourced clinical research. The Consortium develops progressive solutions to some of the greatest challenges faced in clinical research.
The AQC provides our 70+ Member companies with access to a quality oversight framework, which includes 300+ guidelines, tools, templates, and processes across 8 key categories (Governance, Technical Oversight, Process Oversight, Communication, Oversight Leadership Requirements, Metrics/Analytics/Technology, Roles/Responsibilities, and Proactive Risk/Opportunity Management).
If your company is an AQC Member, and you would like more information on accessing these tools, please contact Caryn Laermer. If your company is not a Member, and you are interested in exploring membership to the AQC, please contact Josh Seltzer.
About the Avoca Group
The Avoca Group is an integrated research and consulting firm providing survey research, consulting services and training in the areas of clinical trial outsourcing, business development, strategic alliances and client service to help solve complex clinical trial challenges, improve business relationships, improve quality, and optimize efficiency in the oversight and execution clinical of clinical research. Founded by industry veteran Patricia Leuchten in 1999, the company works exclusively in the health care industry and has a focus on relationship management.
To find out more on how Avoca can help, please contact Beth Listhaus.