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 ...
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 ...
List of acronyms and abbreviations commonly used in clinical trials research. Clinical Trials Glossary List of terms commonly used in clinical trials research. Glossary of Medical Terms in Lay ...
Introduction Demographic change is resulting in a growing number of individuals requiring nursing care, while the ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
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 ...
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 ...
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 ...
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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