Who is responsible for overseeing the use of investigational drugs in a healthcare setting?

The principal investigator and the institution are responsible for overseeing the use of investigational drugs in a healthcare setting because they play a crucial role in ensuring that clinical trials adhere to regulatory guidelines and ethical standards. The principal investigator leads the study, overseeing all aspects including participant safety and compliance with the study protocol. This person is typically a physician or a qualified individual who has the expertise to ensure that the study is conducted properly. The institution, which could be a hospital or clinical research organization, provides the necessary oversight to ensure that all personnel involved in the study are trained and that the investigational drugs are handled according to the specific guidelines. Furthermore, they ensure that good clinical practice is maintained, that informed consent is obtained from participants, and that all adverse events are reported.

In contrast, nurses may administer investigational drugs, but they do not hold the responsibility for the overall oversight of their use. Pharmacy technicians assist in the preparation and distribution of medications but are also not in a position of oversight. Family members of patients are not responsible for overseeing investigational drugs as they do not have the regulatory or ethical authority in a clinical trial setting.