Description
The investigator is responsible for conducting the clinical trial in compliance with the study protocol, GCP, medical ethics, and applicable legal requirements. The clinical research community expects that investigators and clinical staff are fully trained in GCP.
Duties and functions discussed in this session include: provision of adequate resources; liaison with institutional review boards or independent ethics committees (IRBs/IECs); compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.
