Q&A: GCP Training and the New 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) that says NIH-funded investigators and staff should be trained in Good Clinical Practice (GCP).


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. 

Four of CITI Program's GCP courses, and the Spanish and Portuguese translations of the FDA and ICH basic 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
 
  • 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

When is this policy effective?

This policy takes effect 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.
 

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Last Updated: 08-Jan-2018 10:26 a.m. EST
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