Good Clinical Practice (GCP) Training

NIH leadership released a new policy requiring GCP training as of January 1, 2017.

There are three important components of this policy that may require some research teams to take additional GCP training: 

  1. The policy extends to all clinical trials including behavioral interventions.
  2. The entire research team [Principal Investigator (PI) and all clinical trial staff] must complete the training. The training must be updated every three years.
  3. While the new JHM policy only applies to individuals conducting clinical trials, GCP training is relevant to all types of clinical research and will count as a component toward the more general Human Subjects Research Training recertification requirements.

Over the past few years, clinical research leaders have expressed the benefits of GCP training for those wishing to conduct high quality clinical trials. As clinical trials have increasingly become multicenter, the need for common training has become apparent. Many NIH clinical trial groups already require GCP training, as do some corporate sponsors. To avoid confusion, our Johns Hopkins Medicine policy will require up-to-date GCP training for the entire research team, including staff, on all clinical trial protocols no matter who is funding the research. There are "trials" that would not qualify as more than minimal risk that would still require adherence to the NIH policy.