NIH Good Clinical Practice (GCP)

The NIH “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” establishes the expectation that all NIH-funded investigators and clinical trial 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).

• NIH Definition of "Investigator"

  The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. 

• NIH Definition of Clinical Trial Staff

  Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

Required Training

You will find 3 options for meeting the GCP training requirement.

• NIH Good Clinical Practice for Social and Behavioral Research: Complete all 9 NIH online courses. Optional NIH-GCP track includes links to all 9 modules from the Ability system. 
• CITI Programs course GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus): Complete all 10 of the CITI modules which requires following instructions for  login to CITI with your NetID and adding the course group. Your MSU account will be updated approx. 1 week after you complete the 10 modules as long as you use only your netID@msu.edu account. 
• Alternative training review - Submit a request for acceptance of alternate GCP training in lieu of the options above and email documentation of past training.

Refresher Training Requirement

The CITI Programs FDA Refresher must be completed at least every 3 years.

More Information

Please see the HRPP Manual Section 2-2-F-ii, U.S. Department of Health and Human Services National Institutes of Health Good Clinical Practice Training for requirements.

If you have any questions, please feel free to contact the Compliance office at hrl@msu.edu or 517-355-2180.