Who is responsible for ensuring compliance with GCP during a clinical trial?

The responsibility for ensuring compliance with Good Clinical Practice (GCP) during a clinical trial primarily lies with the sponsor, investigators, and the clinical trial staff. Each of these parties plays a vital role in upholding the standards set forth by GCP to protect the rights, safety, and well-being of trial participants while ensuring the integrity of the data collected.

The sponsor, who is typically the entity that initiates and funds the trial, is tasked with overseeing the entire study and ensuring that it adheres to regulatory requirements and GCP guidelines. They are responsible for the design of the trial, as well as for providing the necessary resources and oversight throughout the study.

Investigators, who conduct the trial, must follow GCP guidelines to ensure proper conduct of the study at their sites. They are accountable for the protocol compliance, participant safety, and data integrity, as they have direct interactions with the participants.

Clinical trial staff are also crucial as they support the day-to-day operations of the trial, assisting with participant management, data collection, and adherence to protocols. Collectively, these parties form a compliance network that upholds ethical standards and regulatory requirements during the clinical trial process.

While participants, regulatory agencies, and funding organizations play important roles in the clinical trial