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ATTENTION: The NIH announced new GCP training expectations that are effective January 1, 2017. The new policy requires basic GCP training, and regular refresher GCP training every three years. The policy can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.
The leadership at Fred Hutch and across the Cancer Consortium has determined that all Fred Hutch and Consortium investigators and staff involved in clinical trials, regardless of funding source, will be required to meet the new GCP training requirements as of January 1, 2017. The Fred Hutch or UW Cancer Consortium Principal Investigator of a clinical trial is responsible for ensuring that GCP training has been taken by staff supporting the clinical trial.
If you have documentation or certification that you have taken GCP training more than three years ago, you will need to take a GCP refresher course.
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analyzing and reporting of clinical trials. Compliance with GCP provides assurance that the study data are credible and accurate and that the rights, safety, confidentiality and well-being of research participants are protected.
GCP training is required for all Fred Hutch investigators and clinical trial staff involved in a clinical trial, regardless of funding source.
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.
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.
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.
It depends on your role. If you are the principal investigator on a study submitted to the Fred Hutch IRB, or you are relying on the Fred Hutch IRB through an Individual Investigator Agreement you need to meet the Fred Hutch GCP training requirements.
Other non-Fred Hutch investigators and study staff should meet the requirements of their own institution; the PI is responsible for ensuring all study staff have met the relevant institutional requirements. For more detailed information on who needs to complete GCP training see IRB Policy 2.20 Training.
Fred Hutch or UW Consortium "Sponsor-Investigators" who hold the Investigational New Drug (IND) or Investigational Device Exemption (IDE) for a multi-center trial may be subject to additional training requirements by the Consortium's External Performance Site Assessment Committee (EPSAC). For more information on EPSAC visit the Cancer Consortium website.