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Per NIH’s 16 September 2016 Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials GCP training will be required for all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials.

  • GCP training is required for all NIH funded studies that meet the NIH’s definition of clinical trial.

As of May 1, 2017, IRB approval for new studies and continuing review will not be granted for NIH funded clinical trials until the PI certifies completion of GCP training for the PI and research team.

NIH definition of clinical trial:

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 behavioral outcomes.

  • As of 01 January 2018, GCP training will be required for all clinical trials (all studies that meet the NIH definition of clinical trial) regardless of funding source.
  • To access a GCP course through CITI:
    • 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
  • PI responsibilities related to GCP training:
    • The PI is responsible for compliance with GCP training (for both the PI and research team), and GCP training is subject to audit.
    • The PI is to certify completion of GCP training by specifying the GCP training course name and expiration date on relevant IRB forms. (GCP training is good for 3 years).
    • The PI is to retain documentation of GCP training in study files.
    • This requirement not only applies to clinical trials submitted to the Tufts Health Sciences IRB, but also studies where Tufts has ceded review to another IRB, such as WIRB, CIRB, and any other cede review agreements.