FDA creates clinical trial protections office

The FDA announced on Friday the creation of a new Office for Human Research Trials (OHRT). According to FDA, OHRT "will have a central role in FDA's human subject protection and Good Clinical Practice (GCP) policy and coordinate FDA's bioresearch monitoring program for human clinical trials." OHRT will participate in international GCP and human subject protection activities and GCP education and outreach, and will work closely with the Office for Human Research Protections in the Department of Health and Human Services. ...