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 ...
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 ...
The purpose of this guidance is to explain the roles and responsibilities of both undergraduate and graduate students when submitting protocols to be reviewed by the Institutional Review Board (IRB).
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