Research & Economic Development

Office of the Vice Chancellor

Policy on Good Clinical Practice (GCP) Training


ATTENTION: The NIH recently announced new GCP training expectations that must be met. The new policy requires basic GCP training and refresher GCP training every three years. The policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.

UMKC has determined that all UMKC investigators and staff involved in clinical trials, regardless of funding source, will be required to meet the new GCP training requirements.  The UMKC Principal Investigator of a clinical trial is responsible for ensuring that GCP training has been taken by staff supporting the clinical trial. 

*This will be implemented with all new submissions in the same manner IRB training is.
*For existing projects- Please implement training for all personnel listed on the existing IRB application as soon as possible. 

For training information please go to the CITI IRB training site, https://about.citiprogram.org/en/homepage/ (choose Log in through my Institution to log in with your SSO).

If you have questions or need further assistance with this new GCP training requirement, please contact the IRB at (816) 235-5927 or umkcirb@umkc.edu.

For additional information on the new NIH requirement see http://osp.od.nih.gov/sites/default/files/FAQs_on_NIH_GCP_Policy.pdf 

Training Options:

  • Collaborative Institutional Training Initiative (CITI) online GCP training courses found at http://www.citiprogram.org/
    •  GCP – Social and Behavioral Research Best Practices for Clinical Research (ID: 190017)
    • Good Clinical Practice Course (US FDA focus) (ID: 67399)
    • GCP Course for Clinical Trials Involving Investigational Medical Devices (international focus) (ID: 67398)
    • GCP Course for Clinical Trials Involving Investigational Drugs (international / ICH focus) (ID: 67397)

GCP training offered by Institutes within the NIH, including NIAID and NIDA.   

Other equivalent GCP training such as the Association of Clinical Research Professional’s GCP classroom training course or the Barnett Education Services GCP classroom training course. The IRB will accept other GCP training if the course covered the same topics as CITI and written documentation can be provided.