The University of Pittsburgh recognizes that GCP training is important for all researchers conducting “clinical trials” to ensure the protection of human subjects and the integrity and quality of our research. Therefore, all Investigators and research team members who are engaged in the conduct, oversight or management of clinical trials (* as defined by the NIH) are required to complete the CITI GCP training course before they participate in any research activities. The University has extended 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 (see guidance below) 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. There are (2) GCP training courses available. If you currently participate in an FDA regulated clinical trial or plan to do so in the future, complete the U.S. FDA Focus GCP course. All others should complete the Social and Behavioral GCP course. Re-certification is required every 3 years.
- Good Clinical Practice (CITI)
- GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
- GCP – Social and Behavioral Research Best Practices for Clinical Research
Guidance on who must complete GCP training:
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.
* 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. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html#sthash.U12c4BnW.dpuf