Protocol deviations can be extremely costly to clinical trials - both financially and with patient safety. In some cases, ...

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 ...

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 ...

Using KRIs or SDM, sponsors can detect a variety of emerging risks, including inadequate adverse-event reporting, protocol ...

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 ...

The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns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