NIH Policy on Good Clinical Practice Training
There is a NEW NIH requirement for investigators and clinical trial staff involved in NIH-funded clinical trials to complete Good Clinical Practice (GCP) training. This GCP training is in addition to the current Human Subjects training requirements for those who are involved in human subject research and trials.
This NIH policy is effective as of January 1, 2017.
Please note MUSC has confirmed with NIH that completion of MUSC’s CITI training course/module entitled “Good Clinical Practice and ICH” will satisfy this new requirement.
In the past this particular CITI training module has only been optional at MUSC. However, with this new NIH requirement, MUSC investigators and clinical trial staff must ensure this specific module has been successfully completed before working on any NIH-funded clinical trial on or after January 1st, 2017.
NIH Notice NOT-OD-16-148 announced NIH’s new policy requirement on Good Clinical Practice (GCP) training for Awardees involved in NIH-funded clinical trials.
This notice 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 the principles of the International Conference on Harmonisation (ICH) E6 (R2).1
GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials. The principles were developed in 1996 by the ICH in collaboration with representatives from the European Union, Japan, and the United States. The U.S. Food and Drug Administration (FDA) requires GCP compliance for studies conducted under an investigational new drug application or an investigational device exemption.
GCP training complements other required training on protections for human research participants. Since June 2000, the NIH Extramural Research Program has required training on protections for human research participants for all NIH-funded investigators and individuals responsible for the design or conduct of a research involving human subjects.2
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.3 GCP training includes the principles of ICH GCP found in Section 2 of ICH E6. 4 GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. Completion of GCP training will demonstrate that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants. GCP training should be refreshed at least every three years in order remain current with regulations, standards, and guidelines. Recipients of GCP training are expected to retain documentation of their training.
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.
1 International Conference on Harmonisation (ICH)
2 Required Education in the Protection of Human Research Participants
3 A clinical trial is defined by NIH 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.
4 Acceptable GCP training sites include the NIAID GCP Learning Center website and National Drug Abuse Treatment Clinical Trials Network.