What is the main responsibility of the investigator in relation to an investigational product?

The main responsibility of the investigator in relation to an investigational product is to ensure accountability for the investigational product. This accountability involves maintaining proper control, storage, and handling of the product throughout the clinical trial process. The investigator must adhere to all applicable laws and regulations, as well as Good Clinical Practice (GCP) guidelines to ensure the integrity of the investigational product and protect the safety of trial participants.

This responsibility encompasses tracking product usage, ensuring that only authorized personnel have access to the investigational product, and documenting any changes in the product's status or condition. By ensuring accountability, the investigator plays a critical role in upholding the ethical standards of the trial and maintaining the validity of the data collected.

Other responsibilities tied to the investigator may include ensuring participant safety and compliance with the study protocol, but the specific function of accountability for the investigational product is paramount to the integrity of the research and the trust placed in the clinical trial process. This is central to maintaining compliance with regulatory authorities and ultimately supporting the scientific validity of the study’s outcomes.