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

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 ...

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 ...

Important Note: All IRB protocols for research to be conducted in a foreign country — including survey-only research — must include a completed international research addendum. The international ...

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 ...

List of terms commonly used in clinical trial research. Glossary of Medical Terms in Lay Language Helpful list of medical terms described in lay language. Sample Study Startup Checklist Use this ...

Insurers limit the use of certain prescription drugs by requiring step therapy—that is, by allowing access only after alternatives have been tried and have failed. Using data from seventeen of the ...