As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Interactions between lipids and proteins in the aqueous phases of cells contribute to many aspects of cell physiology. Here we describe a detailed protocol to systematically characterize in ...

In some cases, applications can be based upon industry-accepted standards, as shown in Figure 10-27. For example, for devices that need to be able to connect to other devices to transfer data or to ...

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 ...

Protocols and guidelines for medical and nursing practice and/or treatment are generally developed to target a clinical problem -- hypothermia in the delivery room or neonatal hypoglycemia -- which ...