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The National Institutes of Health (NIH) policy on Good Clinical Practice (GCP) training took effect January 1, 2017. As a result, GCP training will be required for all researchers involved in the conduct, management or oversight of clinical trial research. The NIH also expanded the definition of a clinical trial. A 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 interventions on health-related biomedical or social behavioral outcomes. GCP training is required for all research that meets this definition, regardless of funding source.

Tufts SBER IRB offers GCP training through the CITI site. To access this training, please do the following:

  • Sign in to citiprogram.org
  • Under My Learner Tools for Tufts University/Tufts Medical Center, choose “Add a Course”
  • Answer each question, being sure to Click “Yes” on Question 3 to add “Good Clinical Practice and ICH (GCP) – Basic Course”
  • Hit the “Submit” button
  • GCP should now be listed as a course option under My Learner Tools for Tufts University/Tufts Medical Center Courses for you to complete.

It is the PIs responsibility to ensure that the GCP training is complete and on file for all research team members. Please contact sber@tufs.edu with any questions.