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 ...
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 ...
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 ...
Patterns of Homologous Repair Deficiency and BRCA1/2 Testing of Ovarian and Breast Cancers: A Real-World Study of Patients in Community Health Settings in the United States A joint ASCO and Friends of ...
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The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about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 ...
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