Introduction The increasing incidence of type 2 diabetes mellitus (T2DM) among women of reproductive age poses significant health risks for both mothers and their fetuses. Optimising blood glucose ...
A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...
Institutional Biosafety Committee – recombinant DNA, materials of human or non-human primate origin, toxins, select agents, etc. Radiation Safety Committee – radioactive materials Institutional Review ...
Introduction Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to ...
A single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by federal agencies that are carried out at more than one site in the United ...
Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...
The Principal Investigator (PI) is responsible for reviewing this policy and complying with its requirements. Specifically, the PI will: You may use the protocol template to record your information ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
With decades of conflicting studies on meat and cancer, researchers are cutting through the noise with a high-level review to determine whether red and processed meat truly increase cancer risk—or if ...
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