Definitions and applications of key elements of risk-based quality management will be reviewed: quality by design, critical to quality factors, critical data, and processes, quality tolerance limits and key risk indicators. A case study will be presented to demonstrate their use in a clinical trial and the best practices will be shared.

The modernization of ICH E8 emphasizes a Quality by Design (QbD) approach to clinical trial design. The multi-stakeholder Clinical Trials Transformation Initiative (CTTI) developed an extensive suite of ongoing resources for organizations to learn and teach others how to apply QbD principles in clinical trials. This session will highlight evidence-based recommendations for QbD, case studies, and resources that give sponsors and other stakeholders the tools and confidence needed to effectively implement QbD at their organization.

This session will target several recent examples of common barriers companies continue to face when implementing RBQM. Sculpting a process, understanding stakeholder roles & responsibilities, developing KRIs/QTLs and ongoing monitoring of risk will all be discussed.

The release of ICH E8 R1 (draft) has cemented the direction that the Regulatory bodies want us to follow, that is towards a Quality by Design process, rather than “Quality by Accident” as some regulators have expressed. A background of the Regulatory presentations, guidances and discussions at meetings will be brought together to give their path of attack initially via RBM and now cemented in a compelling need for QbD. This presentation will take you stepwise through the following topics:

•Regulatory background from “crumbs on the ground” to clear direction

•From early presentations from 2000 to recent (2019) Regulatory Guidance

•What is Quality by Design

•How can QbD principals be incorporated into RBM with an example

When looking to create a team to manage risk-based study execution, what are the skills and experience needed? How can roles and responsibilities be managed across the team to cover everything from performing risk assessments, KRI selection and programming, issue detection/action/escalation, QTL selection and tracking, to documentation of actions? We will share our experience and best practices in building a data sciences team and managing risk-based study execution processes.

After a few years of implementation of risk-based monitoring, the need for a more inclusive and global approach became clear. The purpose of this presentation will be to share why and how our company has rebranded its risk-based strategy.

The concept of quality by design has been around for a number of years in clinical trials. By building quality into the protocol design and trial operations from the start, overall quality is improved, and costs should be reduced. But, there are challenges to implementation – the desire to get to "First Patient In" as soon as possible, and the lack of measurement of the costs when things go wrong due to poor design and planning. In this presentation, we explore the concepts of quality by design in ICH E8 (R1) and the cost of quality. We will look at a tool developed by an industry consortium to help assess the cost of poor quality to help with decision making for quality by design.

The ICH revised E6 guidelines was issued to reflect on the current research landscape: increases in globalization, study complexity, and technological capabilities. The updated ICH GCP E6 R2 is more descriptive than the previous version and has 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few.

ICH E6 (R2) addendum highlights the importance of focusing resources on managing critical processes and data, as well as a sponsor’s obligation to ensure oversight of trial-related duties and functions carried out on its behalf. As organizations update their processes to include early identification and oversight of critical processes and data, they are increasing the level of scrutiny of services provided by CROs and other vendors, such as central labs, eCOA, ECG core labs, and imaging core labs. During this session, the presenter will review:

• Sponsor requirements to ensure oversight of CROs and other vendors, as well as vendors contracted by CROs on the sponsor’s behalf
• How to determine which vendors perform critical processes and provide critical data 
• What performance data reported by CROs and/or other vendors allow sponsors to actively manage risks and reduce the likelihood of severe consequence?

This discussion will clarify the definition of “protocol deviation”, review support classification of “important” and “non-important” protocol deviations, and provide a toolkit to support multiple processes associated with protocol deviation management from identification through reporting, including several feedback loops.

ICH E6 R2 calls for the establishment of a system to manage quality throughout all stages of the trial process. This presentation will describe elements of a protocol to CSR quality management process that allows sponsors/CROs to understand risks to GCP and proactively mitigate those risks.