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 four 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)
Refresher Courses - Available in English (Spanish and Portuguese Coming Winter 2017)
- GCP FDA Refresher
- GCP ICH Refresher
- For more information about how to determine if a GCP course meets TransCelerate Minimum Criteria, refer to the CITI Program knowledge base article How to Determine if a GCP Course Meets TransCelerate Minimum Criteria.
- For more information about CITI Program GCP content (including courses offered, module descriptions, and language availability), refer to the GCP Catalog.
- To subscribe as an organization or to purchase a GCP course for an individual learner, please see the GCP subscription details.