In addition to the overall guidance for conducting
clinical research found in GCP guidelines, the practice
of nurses is regulated by state licensing authorities and
further delineated by institutional policy, including
those working with human subjects in the context of
clinical research. As licensed professionals, nurses are
expected to be informed about the scope of practice in
the state in which they work, including delegation
authorities. Activities such as medication administration
vary by state in terms of who is allowed to
administer, supervise administration, and delegate
administration of medications. This issue can cause
significant confusion when research teams discuss, for
example, assignment of the role of dosing and monitoring
healthy subjects in a phase 1 trial or performing
follow-up telephone evaluations to discover and
document possible adverse reactions.