Industry groups are asking the US Food and Drug Administration (FDA) for more clarity about a proposed uniform system for classifying protocol deviations in clinical studies. They say clarification is ...

Reports of noncompliance or protocol deviations must be submitted to the IRB within 48 hours of discovery. Please see this guidance document on how to submit reports. An "incident" should be submitted ...

Two classic translational blocks are compounded by an execution gap characterized by weak cross-functional mobilization, slow ...

The effect of gaps in chemotherapy on survival in patients with high-risk stage II and stage III colon cancer. This is an ASCO Meeting Abstract from the 2012 Quality Care Symposium. This abstract does ...

In the June 2008 “Protocol Review” column, there was a discussion about whether performing fewer procedures than originally planned constitutes a significant deviation that ought to be reported to ...

The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related ...

Both the Animal Welfare Act regulations and the Public Health Service Policy make it clear that prior IACUC approval is required for research procedures using animals. Carrying out procedures that ...

European regulators are warning that clinical trial protocol deviations are "unavoidable" for studies operating in Ukraine amid the Russian invasion, and companies should consider being flexible as ...