Serious breach: Any deviation of the approved protocol version or the clinical trial regulation that is likely to affect the safety, rights of trial participants and/or data reliability and robustness ...

But these little fruits can harbor viruses like norovirus and hepatitis A, which can make you seriously sick. Now, the U.S. Food and Drug Administration (FDA) is continuing to update its food safety ...

The protocol reflects the feedback of these gynecologic oncology experts as well as input from the FDA. The protocol has now also been approved by the Institutional Review Board of the first trial ...

ValGenesis VLMS was chosen to streamline the entire FDA computer system validation ... enabling seamless deviation tracking, and provide electronic execution and approval, ensuring full ...

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, talks FDA’s latest protocol deviation guidance and potential changes to the draft. In a recent ...