Early protocol design decisions carry significant operational consequences for clinical supply strategy and randomization and trial supply management (RTSM) performance. Many issues that emerge ...
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 Maternal and child mortality has markedly decreased worldwide over the past few decades. Despite this success, the decline remains unequal across countries and is overall insufficient to ...
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 ...
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 ...
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback