NIH GCP Request for Alternate Training

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials must be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

Please complete this form if you would like to request acceptance of alternate GCP training. Alternate training must meet the standards for GCP training described in the “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” (dated September 16, 2016: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html).

See HRPP Manual Section 2-2-F-ii, U.S. Department of Health and Human Services, National Institutes of Health Good Clinical Practice for more information.

The date of the GCP training completion must meet the NIH requirement: GCP training should be refreshed at least every three years in order remain current with regulations, standards and guidelines. Alternate GCP training must have been completed within the past three years.

The explanation of the GCP training previously completed must meet the NIH requirement: GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording and reporting trials that involve human research participants.

A copy of the GCP training completion certificate(s) must be emailed to hrl@ora.msu.edu.