ICH E6 describes standards that apply to:

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The correct response encompasses the full scope of parties involved in clinical trials as outlined in ICH E6, which is part of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. ICH E6 provides a comprehensive framework for Good Clinical Practice (GCP), which includes requirements and standards not just for investigators, but also for sponsors and Institutional Review Boards (IRBs).

Investigators are responsible for conducting the trial in accordance with the study protocol and ensuring the safety and welfare of participants. Sponsors, who are typically the organizations that initiate and manage clinical trials, have obligations related to the funding, planning, and oversight of the study. IRBs play a crucial role in protecting the rights and well-being of study participants by reviewing and approving the trial protocols before they commence.

By covering all three groups, ICH E6 ensures that the ethical and scientific quality of trials is maintained across the board, facilitating collaboration and compliance among those who conduct, oversee, and review clinical research.

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