GCP Training Requirement for NIH-Funded Clinical Trials

What is the Requirement for GCP Training?
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).

Who Needs to Complete GCP Training?
This Policy applies to NIH-funded investigators and clinical trial site staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials.

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.

What Training Must be Completed?
At MSU, unless a request for alternate GCP training has been accepted, 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)” (available through CITI) for clinical trials that involve drugs and/or devices, or
  • GCP for Social and Behavioral Research eLearning Course (available through the MSU ORA Learning Management System) 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.

How Do I Submit a Request for Acceptance of Alternate GCP Training?
Requests for acceptance of alternate GCP training may be submitted through the NIH GCP Request for Alternate Training Form

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).

Submitted forms will be sent to an HRPP manager or designee who may accept the training as alternate. Such acceptance must be documented within the HRPP training system.

What Documentation of Training is Required?
Recipients of GCP training are expected to retain documentation of their training. This documentation is available through the ORA Learning Management System.

How Do I Access the Initial Training?

For Clinical Trials that Involve Drugs and/or Devices:

You will need to complete the CITI GCP course “GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)” available through CITI.

  1. Go to https://about.citiprogram.org/en/homepage/
  2. Log In (if you have previously registered)
  3. If you have not registered, register with CITI; please note that Michigan State University uses "Single Sign On" for CITI Program access (on the registration page, click the link "Can't find your institution? It may use Single Sign On. Check here.")
  4. Enroll in the "GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
  5. Complete the course

For Clinical Trials that Do Not Involve Drugs or Devices:

You will need to complete the GCP for Social and Behavioral Research eLearning Course available through the MSU ORA Learning Management System.

  1. Log into the "Saba Learning Management System" (log in accessible at http://ora.msu.edu/train)
  2. Click "Find Training" and search for GCP
  3. Select the "NIH Good Clinical Practice for Social and Behavioral Research" (if you need help enrolling in the course, please contact the Compliance office)
  4. Complete the Learning Assignments

Where Can I Find More Information?
Please see 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 for requirements.

If you have any questions, please feel free to contact the Compliance office.