Who is primarily responsible for ensuring compliance with ICH E6 guidelines during clinical trials?

The sponsor of the clinical trial holds the primary responsibility for ensuring compliance with ICH E6 guidelines throughout the study. According to the ICH E6 guidelines, the sponsor must ensure that the trial is conducted in accordance with Good Clinical Practice (GCP), which includes the design, conduct, oversight, and reporting of clinical research.

The sponsor is responsible for the overall planning and management of the trial, which encompasses the selection of sites, monitoring of trial conduct, ensuring that all personnel are adequately trained, maintaining regulatory documentation, and safeguarding the rights and well-being of trial participants. It's their duty to provide necessary training to the staff conducting the trial and to ensure adherence to ethical norms and regulatory requirements.

In contrast, while governmental regulatory bodies provide oversight and guidelines to safeguard public health, they do not directly manage trial operations. Clinical trial participants contribute to the research but are not responsible for compliance. Independent auditors can assess compliance but are typically not the main actors in ensuring that the trial adheres to the established guidelines; rather, they evaluate and report on compliance after the fact. Thus, the sponsor plays the crucial role in maintaining alignment with ICH E6 standards throughout the clinical trial process.