Regulations for Drug Research - Amy Emerson & Michelle Weitz - Part 2 of 2

Clinical investigators assume legal responsibility for the conduct of drug trials under FDA oversight. This accountability mandates strict adherence to protocol, documentation, and the explicit protection of subject welfare throughout the trial process. Substandard oversight and documentation by primary investigators can lead to negative consequences, including regulatory warning letters and the invalidation of research data. These failures often stem from delegating crucial oversight responsibilities to staff rather than maintaining direct involvement, underscoring the necessity for primary investigators to prioritize rigorous compliance and ethical governance.