Who ultimately holds the responsibility for patient safety and ethical conduct in a clinical trial?

The principal investigator holds the ultimate responsibility for patient safety and ethical conduct in a clinical trial. This role is crucial because the principal investigator is directly engaged in the clinical trial's procedures and is tasked with overseeing the research team and ensuring compliance with the study protocol, ethical standards, and regulatory requirements.

As the individual leading the trial, the principal investigator is accountable for the well-being of the participants, ensuring informed consent is obtained, monitoring adverse events, and maintaining the integrity of the data collected. Their vast oversight encompasses not only the scientific aspects of the study but also the ethical dilemmas that may arise, making their responsibility central to conducting a safe and ethical clinical trial.

While FDA inspectors monitor compliance with regulations, study coordinators assist with the day-to-day operations, and sponsors provide funding and resources for the trial, none of these roles ultimately supersede the principal investigator's duties regarding patient safety and ethical conduct. Thus, it is the principal investigator who directly ensures that all aspects of the trial align with the standards of Good Clinical Practice (GCP).