What is an investigator's responsibility according to GCP?

The investigator’s primary responsibility according to Good Clinical Practice (GCP) is to ensure adherence to the study protocol. This is essential for maintaining the integrity of the clinical trial and the safety of the participants. By following the study protocol, the investigator assures that the trial is conducted consistently and according to established guidelines, which is critical for producing valid and reliable results.

Adherence to the protocol includes managing participant enrollment, ensuring informed consent is obtained properly, and overseeing that all procedures are executed as planned. This responsibility extends to monitoring the conduct of the trial and reporting any deviations or adverse events, which is pivotal for patient safety and data integrity.

While recruiting participants is part of the investigator's role, it is not their sole responsibility, nor does it encompass the full scope of their obligations. Similarly, managing study funding and analyzing trial data, while important components of clinical research, fall outside the primary duty of the investigator as outlined by GCP. The focal point remains on their commitment to the ethical and scientific integrity of the research, which is rooted in strict adherence to the established protocol.