What is required to ensure compliance with GCP standards?

To ensure compliance with Good Clinical Practice (GCP) standards, regular audits and inspections are essential. These activities help in monitoring adherence to GCP guidelines, which are designed to ensure that clinical trials are conducted ethically and that the data generated is credible and reliable.

Audits provide an internal or external review of clinical trial processes, documentation, and adherence to regulatory requirements, while inspections, often conducted by regulatory authorities, assess the overall quality and compliance practices in place at the trial site. Together, these measures help identify areas for improvement, establish best practices, and maintain a high standard of quality in clinical research.

In contrast, options that suggest the elimination of external oversight, decreased training sessions, or increased secrecy undermine the transparency and accountability that are critical components of GCP compliance. Reducing external oversight could lead to increased risks of non-compliance going unnoticed, while inadequate training could result in staff not being fully informed of GCP requirements. Increased secrecy would also contradict the principle of openness to regulatory scrutiny, which is fundamental to maintaining the integrity and ethical conduct of clinical trials.