Achieving Compliance with E6: Exploring the Workflow Challenges

Most sponsors are well aware of the recent revision (R2) of ICH GCP E6, which outlines recommendations to unify standards across the EU, Japan and the U.S. with defined requirements for sponsors regarding the role of monitoring and risk management, there are many factors to consider for a successful implementation.

This article discusses a variety of challenges sponsors may face when preparing to address these recommendations and also examines opportunities to drive greater efficiencies in today’s complex trial ecosystem.

Addressing varying levels of adoption

According to the latest revision, sponsors are tasked with a requirement to employ an adaptable quality management system and are expected to maintain oversight of CROs. But with various tracking systems, vendor logs, CTMS and monitoring platforms, seeing the complete picture can be an overwhelming, error-prone effort.

Covance recognized an opportunity to eliminate cumbersome processes, address data integrity issues and offer greater control over the entire monitoring process. They created Xcellerate Monitoring, an integrated platform offered as full-service offering or SaaS.

For risk-based monitoring, the simplest implementation would be the use of Xcellerate® Risk Assessment Categorization Tool (RACT). Xcellerate outlines valuable questions for discussion along with key considerations in the risk assessment process. Coupled with de-risking a trial in the planning stage, sponsors can easily kick-off a basic risk-based approach.

Strengthening data integrity

To provide background on how Xcellerate Monitoring was designed to expand on the priniciples outlined in RACT while aligning with regulatory guidance and addressing current challenges, the team first started by creating system requirements by creating common use cases that were hindering progress. This included examining escalation capabilities, configurable workflows, robust reporting and search capabilities, multi-platform integration and a full audit trail, among others.

Creating RAPID requirements

In the development process, the team at Covance wanted to link the entities passing between systems, such as risks, actions, protocol deviations, issues, and decisions and decided to create an acronym RAPID.

By linking the entities, each risk is tied to its mitigating actions and the potential decisions that track what was conducted and the outcome of the particular issue. As a result, when tracking and reviewing protocol deviations throughout their life cycle, it’s readily apparent if any follow-up actions took place.

Enhancing existing systems

Given that monitoring is a multifaceted process, many different components within Xcellerate Monitoring were designed to address specific workflows. For example, sponsors previously relied on a CTMS system that didn’t always provide a complete picture. Covance created the Risk and Issue Management system with Xcellerate Monitoring to connect to a sponsor’s CMTS and remain system agnostic while providing alerts and notifications.

With this integration, multiple parties can benefit. A physician is alerted when a new set of protocol deviations arrive in their inbox to review, each with electronic links back to the actual deviation to complete the workflow history. Project managers can also track issues and receive alerts when a status of an issue changes. Within the project team, clinical team leads and clinical research associates (CRAs) gain a full auditable picture of how key risk indicators and sites were reviewed, along with any associated escalations.

By connecting RACT, where risk was identified and scored, with Risk Review, where emerging operational study country and site level risks are reviewed, multiple logs and manual tracking processes are eliminated. Similarly, Medical Review tracks patient safety while the Statistical Review tool allows holistic access to review data trends, such as non-random anomalies and patient recruitment data.

Helping sponsors work towards compliance

Increasing sponsor oversight is an important component of the current ICH GCP E6 guidance that not only provides process transparency but also enables the supporting CRO to gain operational efficiency.

With varying levels of adoption in the field with risk-based monitoring and compliance with the latest guidance, we expect that more sponsors will recognize the value of a comprehensive system for assessing, monitoring and tracking risks. Learn how Xcellerate Monitoring can change the way your teams manage study risks and ensure high-quality, complaint data in our recent webinar.