The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has finalized the ICH GCP Guidelines ICH E6(R3). The ICH reflection paper states the “goal [of this guidance] is to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources that are being employed to support regulatory and other health policy decisions”. Based on previous experience (e.g., ICH E8(R1), ICH E6(R2)), it is expected that key stakeholders of clinical trials will face challenges in operationalizing some of the requirements in the guidelines.
To address these challenges, this initiative is developing solutions that aid in understanding difficult to operationalize aspects of the guidelines. The approach is to deliver solutions developed through collaboration and stakeholder engagement across six focus areas of ICH E6(R3) outlined below. Of the six areas, TransCelerate is partnering with the Association of Clinical Research Organizations (ACRO) to co-develop solutions within two focus areas: risk management and data governance.
Trial Design
Additional resources and solutions coming soon in 2024 and early 2025.
Risk Proportionality
Additional resources and solutions coming soon in 2024 and early 2025.
Risk Management
Focus Area Overview and Objective
TransCelerate has been working with ACRO to co-develop a “Risk Management Toolkit”, which is designed to facilitate the industry’s comprehension and application of changes in risk management, particularly with the transition from ICH E6(R2) to E6(R3). It will provide a suite of resources, including delivered solutions, such as a comparison of ICH E6(R2) and E6(R3) and control strategy considerations, and forthcoming deliverables, such as an anticipated quality management solution. The toolkit will serve as a guide to identify opportunities and challenges, highlight critical changes, and integrate risk management within the framework of ICH E8(R1) principles, such as quality by design and fit-for-purpose. TransCelerate’s work with ACRO supports the industry’s ongoing commitment to the core principles of Good Clinical Practice (GCP) by evolving existing tools and solutions, addressing known areas of improvement, and offering in-depth information for thoughtful consideration during the adoption of ICH E6(R3).
Deliverables
Key Risk Management Changes in Good Clinical Practice [ICH E6(R3)] – Infographic (Co-developed with ACRO)
An infographic that highlights key changes to the risk management elements within Good Clinical Practice Version 2 and 3. Co-developed with ACRO, this infographic aims to allow industry to easily identify the impact to their process and how to react for efficient ICH E6(R3) implementation. Based on Version 3 (draft dated 19 May 2023).
Control Strategies and Good Clinical Practice (ICH E6(R3)) (Co-developed with ACRO)
A considerations tool, co-developed with ACRO, to support the implementation of control strategies under ICH E6(R3) guideline. Application of ICH E6(R3), specifically control strategies in clinical trials, ensure protection of the rights, safety, and well-being of participants and enhance the reliability of study results. Based on Version 3 (draft dated 19 May 2023).
Data Governance
Focus Area Overview and Objective
Data governance is a new section in the ICH E6 guidelines. This section provides guidance for investigators and sponsors on managing data integrity, traceability, and security. It seeks to improve accurate reporting, verification, and interpretation of clinical trial information, complementing the responsibilities outlined in sections 2 and 3, as well as ICH E8(R1), ICH E9, and ICH E9(R1).
To support this new section and uphold ICH principles, TransCelerate and the Association of Clinical Research Organizations (“ACRO”) have co-developed adoption tools, frameworks and templates designed to support GCP stakeholders with compliance, data quality, and decision-making as well as designing fit for purpose systems and processes that meet the evolving clinical research landscape.
Deliverables
Data Governance Framework (Co-developed with ACRO)
The Data Governance framework provides a sample definition of data governance and introduces and connects the other TransCelerate/ACRO data governance solutions to help GCP stakeholders develop a data governance framework.
Data Flow Template (Co-developed with ACRO)
A template to help companies map out relevant data flows between various data collection tools (e.g., EDC, ePRO, eCOA, Central labs) and involved stakeholders (e.g., sponsor, CRO, third-party vendors) in a study. The objective of the tool is to increase clarity and coordination among all parties involved.
Safeguarding Blinding Considerations Tool (Co-developed with ACRO)
The objective of this tool is to explain the concept of safeguarding blinding in clinical research. The document covers topics such as what blinded data is, why data is blinded, the importance of maintaining blinding, who may be unblinded, and the steps to take in case of unblinding.
Technology Framework (Co-developed with ACRO)
This framework explains the computerized systems (CS) requirements outlined in ICH E6(R3). It covers potential procedures for using CS, training, security, validation, periodic reviews, system failure, technical support, and user management. It also includes TransCelerate and ACRO’s proposed definitions and outlines the potential roles and responsibilities of those involved in the process.
Data Matrix Template
Coming soon.
Data Lifecycle Framework
Coming soon.
Monitoring
Additional resources and solutions coming soon in 2024 and early 2025.
Investigators
Additional resources and solutions coming soon in 2024 and early 2025.