The National Institutes of Health (NIH) recently announced a new policy that requires Good Clinical Practice (GCP) training for all NIH funded “clinical trials” effective on January 1, 2017. All Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials (as defined by the NIH) must complete the CITI GCP training course before they participate in any research activities effective January 1, 2017. The University is extending this requirement to all research studies that meet the definition of a clinical trial regardless of the funding source. It is the responsibility of the Principal Investigator to ensure that all members of the research team who meet this requirement complete GCP training and maintain certification during the course of the study. As of January 1, 2017, the Institutional Review Board (IRB) will not approve a new “clinical trial” submission unless GCP training is complete. Although old “clinical trial” submissions such as renewals for those that were effective on Jan. 1, 2017 can be approved by the IRB without complete GCP training, the IRB will encourage and assist in bringing these old trials into compliance with the GCP policy as soon as possible.
The NIH defines a clinical trial as: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
There are two GCP training courses available. If you currently participate in an FDA regulated clinical trial or plan to do so in the future, complete the FDA regulated GCP course. All others should complete the Behavioral or non-FDA regulated GCP course. Re-certification is required every 3 years.
CITI Good Clinical Practice
- GCP for Clinical Trials Involving FDA regulated research
- GCP for Clinical Trials Involving Behavioral or non-FDA regulated research
Those required to take GCP training include those who:
- Manage participant recruitment and enrollment, including obtaining consent
- Perform research procedures or evaluations
- Contribute significantly to the collection and recording of research data or
- Contribute significantly to data management
- Have more than minimal contact with the research subjects or their identifiable study records or specimens
Those not required to take GCP training include:
Hospital staff (including nurses, residents, fellows, or office staff) who provide ancillary or intermittent care but do not make a direct and significant contribution to the study or administrators or individuals who perform routine or supportive tasks related to the research.