Preliminary Insights and Common Concerns

The International Council for Harmonisation (ICH) is in the process of revising its E6 guidelines. The draft ICH E6(R3) guidelines bring significant changes to the clinical research landscape, with a critical focus on the sponsor’s responsibilities. To help you navigate these potential changes, we’ve created an informative infographic that breaks down the key points in a visually engaging way.

Understanding the Draft ICH E6(R3) Guidelines 

The draft ICH E6(R3) guidelines emphasize the importance of sponsors in ensuring the quality and integrity of clinical trials. Sponsors are tasked with various responsibilities, from designing and conducting trials to ensuring data integrity and participant safety.

Key Responsibilities Outlined in the Draft Guidelines 

Our infographic provides a compact overview of these potential responsibilities, including:

  1. Quality Management: Sponsors may be expected to integrate quality management systems into their trials, ensuring that quality is built into the design and conduct of the trial.
  2. Risk Management: Sponsors may be tasked with identifying, assessing, controlling, communicating, and reviewing risks at both the system and clinical trial level.
  3. Data Integrity: Sponsors may need to ensure the integrity of the data collected during the trial, including its accuracy, completeness, and reliability.
  4. Participant Safety: The safety and rights of trial participants are paramount. Sponsors may be responsible for ensuring these are upheld throughout the trial.
  5. Record Keeping: Sponsors may need to maintain thorough and accurate records throughout the trial, ensuring that all essential documents are readily available for review.

Common Concerns in Draft ICH E6(R3) Implementation 

As we’ve been analyzing the feedback on the draft of ICH E6(R3), a commonly shared concern among stakeholders is the need for clarity and consistency in defining the roles and responsibilities of sponsors and investigators, particularly in the context of outsourcing or delegating tasks.

Many stakeholders expressed confusion over the terms “transfer” and “delegate” and how these apply to different parties. They suggested that the guidelines should clearly define these terms and consistently use them to avoid ambiguity.

Another shared concern is the need for clear guidelines on oversight and supervision when tasks are outsourced or delegated. Stakeholders suggested that the party that selects and contracts with a service provider should be the one responsible for overseeing that provider’s conduct of the trial.

Conclusion: Preparing for Potential Changes 

Understanding and fulfilling these responsibilities is crucial for sponsors to ensure the success of their clinical trials. Our infographic provides a clear, concise overview of these potential responsibilities, making it a valuable resource for any sponsor navigating the draft ICH E6(R3) guidelines.

  • Download our preliminary infographic on sponsor responsibilities under draft ICH E6(R3). We believe it will serve as a handy guide for sponsors and clinical research professionals, helping them prepare for potential changes in clinical trials.

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