A new addendum to the ICH Good Clinical Practice (GCP) Guideline carries broad implications for sponsors, CROs, and investigators. The guideline, now known as ICH E6 (R2), was drafted in response to advances in technology within clinical trials (e.g. electronic data recording and reporting, centralized monitoring) since E6 (R1) was prepared. The new addendum aims to “encourage implementation of improved and more efficient approaches to clinical design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results.”

Why does this matter for sponsors? The addendum’s changes could transform how clinical monitoring and trial management are conducted by “requiring the adoption of centralized, quality risk management (QRM) throughout the trial lifecycle.” Sponsors must satisfy the principles of a quality management system (QMS) based on the risks and potential errors in critical data and processes. To address identified significant non-compliance, the guidance provides three principles for sponsors to follow: significant non-compliance identification, root cause analysis, and custom made corrective and preventative action. Moving forward, sponsors will need to maintain oversight of tasks delegated to CROs, placing responsibility on the CRO to maintain effective systems to track data and tasks during clinical research.

The guidance also introduces a new framework to encourage sponsors to adopt innovative technologies. An overview of the new addendum describes the three main concerns addressed by this new framework. First, the framework specifies requirements for the validity, longevity, and fidelity of trial data as sponsors transition from physical to digital records and update or change between digital systems. Second, it encourages “standard processes to avoid situations where real-time data aggregation and visualization may inadvertently influence trial outcomes inappropriately early in the trial process.” Third, the framework expands upon the need for control by investigators of their generated data and documents.

Risk-based quality management, risk-based monitoring, and CRO oversight sum up the three main roles and responsibilities outlined in the addendum. Reviewing and understanding the full addendum will be vital in your preparation for the upcoming changes. Please contact us at Pearl Pathways to discuss the needs of your clinical research.