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).”
CITI Program GCP training is used by over 1,500 institutions – (including many leading hospitals, academic medical centers, universities, and healthcare companies) – to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.
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
- 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.
* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.