MSU HRPP Manual Section 2-2-F-ii

2-2-F-i, U.S. Department of Health and Human Services,  National Institutes of Health Good Clinical Practice 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).

Initial Training
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.

Refresher Training
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.

Alternate Training
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.

Documentation of Training
Recipients of GCP training are expected to retain documentation of their training.

Definitions
For purposes of this section, the following definitions apply:

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. 

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.

Clinical trial: See HRPP Manual Section 2-2-F-i, National Institutes of Health Definition of a Clinical Trial, for a definition of a clinical trial.

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 2-20-2017.

Related HRPP Manual Sections

Approved PDF Version

Please note that hyperlinks have been added to the web version of this document for ease of use. View approved PDF version of Section 2-2-F-ii, U.S. Department of Health and Human Services, Good Clinical Practice Training.