Tag: Protocol deviations

According to regulatory guidelines, researchers must report specific new information to an Institutional Review Board (IRB) to protect human subjects. This is a critical component of ethical research, ensuring that any unforeseen issues are promptly addressed by the governing body. This guide explains the core concept of RNI and its vital role in research compliance.

Fatal adverse events, a specific type of Reportable New Information (RNI), must be reported to the IRB within 24 hours of discovery. This critical component of ethical oversight defines what is RNI in clinical research, ensuring the protection of human subjects throughout a study.