has recently enacted a policy,
effective January 1, 2017, requiring clinical investigators and clinical trial
staff who are responsible for the conduct, management and oversight of
NIH-funded clinical trials be trained in Good Clinical Practice (GCP),
consistent with principles of the International Conference on Harmonisation
(ICH) E6 (R2).
comply with these requirements, all investigators and research staff members
within the College of Medicine funded by or involved in an NIH-supported study
meeting the definition of a clinical trial are required to complete GCP
clinical trial is defined
by NIH as a “research study in which one or more human subjects are
prospectively assigned to one or more interventions (which may include placebo
or other control) to evaluate the effects of those intervention on
health-related biomedical or behavioral outcomes.”
and staff are required to take one of the following GCP trainings through the
Collaborative Institutional Training Initiative (CITI) Program to satisfy the
Biomedical Research: “Good Clinical Practice and
Social or Behavioral Research: “Good Clinical
Practices for Social and Behavioral
taken through CITI will be automatically recorded in ORRP database.
questions related to this new NIH-imposed training requirement, please contact
of Medicine Office of Research.