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CITI Program GCP Training Complies with NIH Policy

On 16 September 2016, the National Institutes of Health (NIH) issued a new policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) stating that NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP). This policy takes effect 1 January 2017. The policy applies to all NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).” The CITI Program offers several GCP courses that are acceptable GCP training for the NIH policy. These GCP ICH E6 Investigator Site Training courses also meet the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Acceptable GCP Courses

Basic Courses - Available in English, Spanish, and Portuguese

  • GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  • GCP for Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
  • GCP - Social and Behavioral Research Best Practices for Clinical Research (Note: Does not meet TransCelerate criteria and only available in English)
Refresher Courses - Available in English and Spanish
  • GCP FDA Refresher
  • GCP ICH Refresher

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