Momentum Events’ ICH E6(R3) Clinical Trials Virtual Conference, which took place in early September 2023, featured esteemed clinical trial quality management professionals, who delved deep into the transition from ICH E6(R2) to ICH E6(R3). As the clinical trial industry witnesses rapid evolution, this transition emerges as a significant pivot, dictating the future roadmap of clinical research and system implementations. This article will delve into some discussions, offering insights into this transition.

Digital Evolution in Clinical Trials: ICH E6(R3) Clinical Trials at the Forefront

The shift from ICH E6R2 to ICH E6(R3) isn’t merely an upgrade; it’s an evolution. There was an emphasis on the digital transformation ushered in by ICH E6(R3), particularly in the domain of clinical systems:

  • Transparency and Knowledge Sharing: The new guidelines advocate a more transparent approach. For instance, there was a discussion introducing training sessions for system developers, emphasizing familiarization with known quality tools such as 21 CFR part 11 and Annex 11.
  • System Functionality and User-Centric Design: ICH E6(R3) stresses the importance of ensuring robust system functionalities. Discussions highlighted involving user groups, like healthcare professionals, to provide invaluable feedback, ensuring systems meet the evolving needs of the industry.
  • User Authorization and Data Security: The emphasis on user authorization and data security is palpable. Unique user IDs, advanced password management measures, and traceability are some of the focal points speakers touched upon.

Patient Safety and Data Integrity: Core Pillars of ICH E6(R3)

Patient safety and data integrity remain at the heart of ICH E6(R3). The conference focused on the profound implications of systems on data quality, patient safety, and trial results.

  • Focus on Data Impact: Speakers discussed the system’s impact on data quality, patient safety, and the reliability of trial results. The emphasis isn’t just on ensuring that systems capture accurate data and comprehending the broader implications of this data on clinical trials.
  • System Functionality and Patient Well-being: Beyond the technical functionalities, systems should prioritize patient safety. Speakers highlighted the importance of robust system functionalities that align with the goals of clinical trials, ensuring that patient well-being remains paramount.
  • Data Integration and Harmonization: Integrating and harmonizing data becomes crucial with diverse data sources and varied patient profiles. Speakers pointed out the importance of ensuring potential participants are matched accurately with trials aligning with their health profiles.

Adaptability and Collaboration: The Imperatives of Transition

The transition to ICH E6(R3) is not a solitary endeavor. Speakers emphasized the role of adaptability and collaboration in ensuring a smooth transition:

  • Beyond Uniformity: The clinical trials landscape is diverse. While guidelines provide a roadmap, speakers highlighted the importance of understanding that a “one-size-fits-all” approach might not always be feasible. Each business unit, with its unique challenges and requirements, needs to adapt the guidelines accordingly.
  • Engaging Stakeholders: Collaboration emerges as a pivotal element. Engaging with different stakeholders, be it system developers, healthcare professionals, or regulatory bodies, ensures a holistic approach to implementation.
  • Continuous Feedback Loop: The transition isn’t a one-time process. Continuous feedback, evaluations, and iterations are crucial. Speakers underscored the significance of taking feedback from user groups and integrating it, ensuring that the systems evolve in tandem with industry needs.

Challenges and the Path Forward

Every evolution comes with its set of challenges. The shift to ICH E6(R3), while promising, brings forth intricate challenges:

  • Data Quality and Consistency: With diverse data sources, ensuring consistent data quality becomes paramount. Any lapse might lead to inadvertent inclusion or exclusion of participants, potentially skewing trial outcomes.
  • Remote Data Acquisition: The reliability of devices and platforms, especially in remote settings, is vital. Inaccuracies can mischaracterize potential candidates, leading to potential pitfalls in the trial process.
  • Data Integration and Harmonization: With the vast amount of data collected, its integration and harmonization become vital. Integrating disparate data sources is pivotal to accurate participant-trial matching.


The transition from ICH E6R2 to ICH E6(R3), paints a promising yet challenging landscape for the clinical trials industry. While the potential for revolutionizing clinical research is immense, the industry’s commitment to navigating the intricate challenges will dictate the success of this evolution.

For more information on ICH E6(R3) check out the full-day workshop at the upcoming 2nd GCP Inspection Readiness Hybrid Conference on December 4-6 in Philadelphia.  Register with discount code CVAN to save 10% AND receive complimentary access to the recorded presentations from the September 7, 2023 ICH E6(R3) virtual event featured in this article.   

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.