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Effective January 1, 2017, Good Clinical Practice (GCP) training is required for all Fred Hutch personnel involved in the design, conduct, oversight, or management clinical trials conducted at Fred Hutch or through the Fred Hutch/University of Washington Cancer Consortium. Training must be completed every three years. For additional information, refer to the training policy above.
GCP training is required for all Fred Hutch investigators and clinical trial staff involved in a clinical trial. Definitions:
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.
Fred Hutch or UW Consortium "Sponsor-Investigators" who hold the Investigational New Drug (IND) or Investigational Device Exemption (IDE) for a multi-center study 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.
You need to take a basic course if you have never had GCP training before. Accepted courses include:
You need refresher training within 3 years after completing a previous GCP course. Accepted courses include:
Go to Hutch Learning to access GCP curricula.
Completion of CITI training is entered automatically in Hutch Learning. There may be up to a week delay for Hutch Learning to reflect your completion status. (Note, you have to associate to Fred Hutch when enrolling in CITI courses for completion to be accurately recorded.) If you have taken other training that meets the GCP training requirements, please send documentation to email@example.com.