In this free webinar, gain insight into why eligibility is a high-impact point for protocol deviation prevention. The featured speakers will discuss how to drive protocol compliance with centralized ...
Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...
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 ...
Evaluating compliance of NCCN cancer and chemotherapy-induced anemia guidelines in a community healthcare setting. This is an ASCO Meeting Abstract from the 2020 ASCO Quality Care Symposium. This ...
On March 18, the Food and Drug Administration issued a guidance for industry, investigators, and Institutional Review Boards on the “Conduct of Clinical Trials of Medical Products During COVID-19 ...
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 ...
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results