A patient-centered methadone restart protocol considers interim opioid tolerance, allowing higher restart doses without compromising safety or treatment retention. The study showed reduced emergency ...

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 ...

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) has recently issued guidance for sponsors and investigators interested in submitting a non-interventional study, commonly known as an observational study, ...

Their shared dedication reflects a broader mission to bring meaningful change to women’s health, offering hope and tangible ...

This guidance provides directions for researchers using measures that involve questions related to suicidal ideation. Research shows that asking questions related to suicidal ideation (SI) does not ...

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and ...