A Note to File provides way to describe and document deviations, problems, or events occurring
during the conduct of research which cannot be documented in a standard case report (CRF) form or
research record. A Note to File can also be used to document specific regulatory requirements for a
study, document receipt of new information about an intervention, or catalog site-specific protocol
requirements. A Note to File essentially provides a way for a researcher or research team to
document information which does not easily fit into other standardized forms.