Protocol Deviation Code

A classification of protocol deviation data.

An unintended departure from the study plan which has not been prospectively reviewed and approved by the IRB and FDA.

The Protocol Development Shared Resource provides Cancer Center investigators with support in clinical and experimental research protocol development, including protocol content and…

A clinical study protocol review status designating the protocol that was deferred pending additional information or/and action(s).

A person at a business or administrative group that retains the responsibility for regulation compliance and ensures the proper administration of the…

A person at the primary location of research that retains the responsibility for regulation compliance and ensures the proper administration of the…