FDA Issues Guidance for Clinical Research Investigators
Posted by Christine Pierre on Tue, Oct 27, 2009
Protecting the rights, safety and welfare of study subjects is the number one priority when conducting clinical research.
The FDA recently released (in October 2009) a "Guidance for Industry" paper which provides Clinical Research Investigators guidance on their responsibilities in protecting the rights, safety and welfare of study subjects. This guidance paper contains numerous expectations and clarity of how Investigators should be managing and conducting their clinical research. more...