New GCP Training Requirement for NIH-Funded Clinical Trials
The National Institutes of Health (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 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).
At MSU, such individuals are required to complete either the CITI GCP course “GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)” for clinical trials that involve drugs and/or devices or the GCP for Social and Behavioral Research eLearning Course for social / behavioral clinical trials or clinical trials that do not involve drugs or devices.
The training must be refreshed at least every three years in order remain current with regulations, standards and guidelines. The CITI FDA Refresher will be required to meet the refresher requirements.
Requests for acceptance of alternate training may be submitted to an HRPP manager or designee. 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). The HRPP manager may accept the training as alternate. Such acceptance must be documented within the HRPP training system.
Recipients of GCP training are expected to retain documentation of their training.
The new HRPP Manual Section 2-2-F-ii, U.S. Department of Health and Human Services National Institutes of Health Good Clinical Practice Training encompasses these requirements.
In addition, the new HRPP Manual Section 2-2-F-i, U.S. Department of Health and Human Services National Institutes of Health Definition of a Clinical Trial provides the current NIH definition of a clinical trial.