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) that says NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP) at least every three years in order to remain current.
Who does this new policy apply to?
The NIH (2016) policy states that 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).”
Is GCP training the same as human subjects protection training?
No. GCP training is an additional separate training and is not basic human subjects protection training. GCP principles are specific to clinical trials and include international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.
Does CITI Program offer GCP training that is compliant with the NIH policy?
Yes. CITI Program offers GCP courses that are acceptable GCP training for the NIH policy. Learners will receive a completion report documenting the successful completion of CITI Program training.
Five of the CITI Program’s GCP courses, and the Spanish and Portuguese translations of those 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 Training for NIH Policy on Good Clinical Practice Training
*These courses 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.
- 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
- GCP FDA Refresher*
- GCP ICH Refresher*
- GCP SBR Advanced Refresher*
When is this policy effective?
This policy is effective as of 1 January 2017.
Who else requires GCP compliance?
The U.S. Food and Drug Administration (FDA) requires GCP compliance for studies conducted under an investigational new drug application or investigational device exemption.
For more information about how to determine if a GCP course meets TransCelerate BioPharma Minimum Criteria, refer to the CITI Program Support Center article How to Determine if a GCP Course Meets TransCelerate BioPharma 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.